Trial Outcomes & Findings for A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever (NCT NCT05480800)
NCT ID: NCT05480800
Last Updated: 2025-11-28
Results Overview
The solicited administration site events included redness (erythema), pain, and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)
Results posted on
2025-11-28
Participant Flow
Participant milestones
| Measure |
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA low dose vaccine and 3 doses of TCV low dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
16
|
16
|
10
|
45
|
45
|
15
|
|
Overall Study
COMPLETED
|
4
|
4
|
14
|
15
|
10
|
45
|
43
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA low dose vaccine and 3 doses of TCV low dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever
Baseline characteristics by cohort
| Measure |
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA low dose vaccine and 3 doses of TCV low dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
n=15 Participants
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.7 Years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
28.2 Years
STANDARD_DEVIATION 6.3 • n=60 Participants
|
28.5 Years
STANDARD_DEVIATION 6.3 • n=65 Participants
|
33.1 Years
STANDARD_DEVIATION 11.3 • n=92 Participants
|
21.8 Years
STANDARD_DEVIATION 2.5 • n=30 Participants
|
35.8 Years
STANDARD_DEVIATION 12.0 • n=30 Participants
|
36.8 Years
STANDARD_DEVIATION 11.1 • n=60 Participants
|
29.7 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
30.3 Years
STANDARD_DEVIATION 8.6 • n=14 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=21 Participants
|
26 Participants
n=60 Participants
|
23 Participants
n=65 Participants
|
10 Participants
n=92 Participants
|
4 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
5 Participants
n=5 Participants
|
90 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=21 Participants
|
19 Participants
n=60 Participants
|
22 Participants
n=65 Participants
|
6 Participants
n=92 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=60 Participants
|
10 Participants
n=5 Participants
|
65 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=21 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=65 Participants
|
16 Participants
n=92 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
15 Participants
n=60 Participants
|
0 Participants
n=5 Participants
|
48 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=21 Participants
|
45 Participants
n=60 Participants
|
45 Participants
n=65 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
14 Participants
n=5 Participants
|
104 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=21 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)Population: The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited administration site events included redness (erythema), pain, and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, Saline
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, iNTS-TCV full dose
|
—
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, iNTS-GMMA full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, TCV full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, Placebo
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, iNTS-TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, saline
|
—
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, iNTS-GMMA low dose
|
—
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, TCV low dose
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, iNTS-TCV full dose
|
—
|
16 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, iNTS-GMMA low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, iNTS-TCV Low
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, saline
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, iNTS-GMMA low dose
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, iNTS-TCV full dose
|
—
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, iNTS-GMMA full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, TCV full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, iNTS-GMMA full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, TCV full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, Placebo
|
—
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, Placebo
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, iNTS-TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57)Population: The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, Placebo
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, iNTS-TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, saline
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, iNTS-GMMA low dose
|
—
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, TCV full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, TCV low dose
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, iNTS-TCV full dose
|
—
|
15 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, iNTS-GMMA full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, TCV full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, iNTS-TCV Low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, saline
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, iNTS-GMMA low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, iNTS-TCV full dose
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, TCV full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, Placebo
|
—
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, iNTS-TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, iNTS-GMMA full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, Saline
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, iNTS-GMMA low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, Placebo
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, iNTS-TCV full dose
|
—
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, iNTS-GMMA full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169)Population: The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=13 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=3 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=14 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, TCV full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, iNTS-GMMA full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, Saline
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, iNTS-GMMA low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, iNTS-TCV full dose
|
—
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, iNTS-GMMA full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, TCV full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, Placebo
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, iNTS-TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, saline
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, iNTS-GMMA low dose
|
—
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, iNTS-TCV full dose
|
—
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, iNTS-GMMA full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, TCV full dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, Placebo
|
—
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, iNTS-TCV Low
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, saline
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, iNTS-TCV full dose
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, iNTS-TCV low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, iNTS-GMMA low dose
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, Placebo
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)Population: The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (\>=) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
Arthralgia
|
—
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
Fatigue
|
—
|
7 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
11 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
Headache
|
—
|
6 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
Myalgia
|
—
|
6 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
Fever
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57)Population: The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration
Arthralgia
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration
Fatigue
|
—
|
7 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration
Headache
|
—
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration
Myalgia
|
—
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the Second Study Intervention Administration
Fever
|
—
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169)Population: The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=13 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=3 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=14 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
Arthralgia
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
Fatigue
|
—
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
Headache
|
—
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
Myalgia
|
—
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
10 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
Fever
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 28 days post vaccination (day of administration and 27 subsequent days post-first vaccination on Day 1)Population: The analysis was performed on the unsolicited safety set, which included all participants who received the first dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints.
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any Unsolicited Adverse Events (AE) After the First Study Intervention Administration
|
—
|
14 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
13 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 28 days post vaccination (day of administration and 27 subsequent days post-second vaccination on Day 57)Population: The analysis was performed on the unsolicited safety set, which included all participants who received the second dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration
|
—
|
8 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 28 days post vaccination (day of administration and 27 subsequent days post-third vaccination on Day 169)Population: The analysis was performed on the unsolicited safety set, which included all participants who received the third dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=13 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=3 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=14 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration
|
—
|
3 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)Population: The analysis was performed on the exposed set, which included all participants who received at least 1 dose of the study intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any Serious Adverse Events (SAEs)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. AEs/SAEs that lead to withholding of the study intervention administration were considered under this outcome measure. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 8 (7 days after the first study intervention administration) compared to Baseline (Day 1)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\], and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 8)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Within (baseline) - within (Day 8)
|
—
|
14 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Within (baseline) - within (Day 8)
|
—
|
13 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Above (baseline) - within (Day 8)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Above (baseline) - above (Day 8)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Within (baseline) - within (Day 8)
|
—
|
14 Participants
|
9 Participants
|
4 Participants
|
3 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Above (baseline) - above (Day 8)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Above (baseline) - above (Day 8)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Within (baseline) - within (Day 8)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Within (baseline) - above (Day 8)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Within (baseline) - within (Day 8)
|
—
|
12 Participants
|
9 Participants
|
4 Participants
|
3 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Above (baseline) - within (Day 8)
|
—
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Within (baseline) - above (Day 8)
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Within (baseline) - within (Day 8)
|
—
|
11 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Within (baseline) - above (Day 8)
|
—
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Within (baseline) - within (Day 8)
|
—
|
15 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Above (baseline) - within (Day 8)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Within (baseline) - above (Day 8)
|
—
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Above (baseline) - above (Day 8)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Below (baseline) - within (Day 8)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Within (baseline) - within (Day 8)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Within (baseline) - within (Day 8)
|
—
|
16 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Within (baseline) - within (Day 8)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Within (baseline) - above (Day 8)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Within (baseline) - within (Day 8)
|
—
|
16 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Within (baseline) - within (Day 8)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 64 (7 days after the second study intervention administration) compared to Baseline (Day 57)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 64 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 64)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Within (baseline) - within (Day 64)
|
—
|
12 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Above (baseline) - within (Day 64)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Above (baseline) - above (Day 64)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Within (baseline) - within (Day 64)
|
—
|
13 Participants
|
10 Participants
|
4 Participants
|
2 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Above (baseline) - within (Day 64)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Above (baseline) - above (Day 64)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Within (baseline) - within (Day 64)
|
—
|
14 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Above (baseline) - above (Day 64)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
3 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Within (baseline) - within (Day 64)
|
—
|
11 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Above (baseline) - within (Day 64)
|
—
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Within (baseline) - above (Day 64)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Above (baseline) - above (Day 64)
|
—
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Within (baseline) - within (Day 64)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Within (baseline) - above (Day 64)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Above (baseline) - above (Day 64)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Within (baseline) - below (Day 64)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Within (baseline) - within (Day 64)
|
—
|
14 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 176 (7 days after the third study intervention administration) compared to Baseline (Day 169)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 176)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=13 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=3 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=14 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Within (baseline) - within (Day 176)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Within (baseline) - within (Day 176)
|
—
|
13 Participants
|
9 Participants
|
3 Participants
|
4 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Within (baseline) - within (Day 176)
|
—
|
11 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Above (baseline) - within (Day 176)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Within (baseline) - above (Day 176)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Within (baseline) - within (Day 176)
|
—
|
12 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Above (baseline) - within (Day 176)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Within (baseline) - within (Day 176)
|
—
|
10 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Within (baseline) - above (Day 176)
|
—
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Above (baseline) - above (Day 176)
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Within (baseline) - within (Day 176)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Within (baseline) - within (Day 176)
|
—
|
8 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Above (baseline) - within (Day 176)
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Within (baseline) - above (Day 176)
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Above (baseline) - above (Day 176)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Within (baseline) - within (Day 176)
|
—
|
9 Participants
|
10 Participants
|
3 Participants
|
2 Participants
|
12 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Above (baseline) - within (Day 176)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Within (baseline) - above (Day 176)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Above (baseline) - above (Day 176)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Within (baseline) - within (Day 176)
|
—
|
13 Participants
|
9 Participants
|
3 Participants
|
4 Participants
|
12 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Within (baseline) - within (Day 176)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Within (baseline) - within (Day 176)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Within (baseline) - within (Day 176)
|
—
|
12 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Within (baseline) - above (Day 176)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 29 (28 days after the first study intervention administration) compared to Baseline (Day 1)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 29 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 29)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Within (baseline) - within (Day 29)
|
—
|
15 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Above (baseline) - above (Day 29)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Below (baseline) - within (Day 29)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Within (baseline) - within (Day 29)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Within (baseline) - within (Day 29)
|
—
|
16 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Within (baseline) - within (Day 29)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Within (baseline) - above (Day 29)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Within (baseline) - within (Day 29)
|
—
|
16 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Within (baseline) - within (Day 29)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Above (baseline) - above (Day 29)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Within (baseline) - within (Day 29)
|
—
|
13 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Above (baseline) - within (Day 29)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Above (baseline) - above (Day 29)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Within (baseline) - within (Day 29)
|
—
|
14 Participants
|
9 Participants
|
4 Participants
|
3 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Above (baseline) - within (Day 29)
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Within (baseline) - within (Day 29)
|
—
|
16 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Within (baseline) - within (Day 29)
|
—
|
12 Participants
|
9 Participants
|
4 Participants
|
3 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Above (baseline) - within (Day 29)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Within (baseline) - above (Day 29)
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Above (baseline) - above (Day 29)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Within (baseline) - within (Day 29)
|
—
|
14 Participants
|
10 Participants
|
3 Participants
|
2 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Within (baseline) - above (Day 29)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Within (baseline) - within (Day 29)
|
—
|
14 Participants
|
10 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Above (baseline) - within (Day 29)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Within (baseline) - above (Day 29)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 85 (28 days after the second study intervention administration) compared to Baseline (Day 57)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 85 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 85)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Within (baseline) - within (Day 85)
|
—
|
13 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Above (baseline) - above (Day 85)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Within (baseline) - within (Day 85)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Above (baseline) - within (Day 85)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Within (baseline) - above (Day 85)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Within (baseline) - within (Day 85)
|
—
|
11 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Above (baseline) - within (Day 85)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Within (baseline) - above (Day 85)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Above (baseline) - above (Day 85)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Within (baseline) - within (Day 85)
|
—
|
13 Participants
|
10 Participants
|
4 Participants
|
3 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Above (baseline) - within (Day 85)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Within (baseline) - within (Day 85)
|
—
|
12 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
11 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Within (baseline) - above (Day 85)
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Above (baseline) - above (Day 85)
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
10 Participants
|
4 Participants
|
3 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 197 (28 days after the third study intervention administration) compared to Baseline (Day 169)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 197 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 197)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=13 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=3 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=14 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Above (baseline) - above (Day 197)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Within (baseline) - within (Day 197)
|
—
|
10 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Above (baseline) - within (Day 197)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Within (baseline) - above (Day 197)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Within (baseline) - within (Day 197)
|
—
|
12 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Within (baseline) - within (Day 197)
|
—
|
11 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Within (baseline) - above (Day 197)
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Above (baseline) - above (Day 197)
|
—
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Within (baseline) - within (Day 197)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Within (baseline) - within (Day 197)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Within (baseline) - within (Day 197)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Within (baseline) - below (Day 197)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Within (baseline) - within (Day 197)
|
—
|
11 Participants
|
9 Participants
|
3 Participants
|
4 Participants
|
12 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Within (baseline) - above (Day 197)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Within (baseline) - within (Day 197)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Within (baseline) - within (Day 197)
|
—
|
13 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Within (baseline) - below (Day 197)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Within (baseline) - within (Day 197)
|
—
|
9 Participants
|
9 Participants
|
3 Participants
|
3 Participants
|
11 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Above (baseline) - within (Day 197)
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Above (baseline) - above (Day 197)
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Within (baseline) - within (Day 197)
|
—
|
11 Participants
|
10 Participants
|
2 Participants
|
3 Participants
|
13 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Above (baseline) - within (Day 197)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Above (baseline) - above (Day 197)
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells (WBC) · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells (WBC) · Within (baseline) - below (Day 197)
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells (WBC) · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells (WBC) · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells (WBC) · Within (baseline) - within (Day 197)
|
—
|
12 Participants
|
10 Participants
|
2 Participants
|
4 Participants
|
12 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells (WBC) · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells (WBC) · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells (WBC) · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells (WBC) · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)Population: The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, TCV full dose
|
—
|
0 Participants
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, iNTS-GMMA full dose
|
—
|
0 Participants
|
—
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, control
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, iNTS-TCV full dose
|
—
|
0 Participants
|
—
|
0 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, saline
|
—
|
5 Participants
|
—
|
0 Participants
|
16 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, TCV full dose
|
—
|
0 Participants
|
—
|
20 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, iNTS-GMMA full dose
|
—
|
0 Participants
|
—
|
41 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Pain, control
|
—
|
6 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, iNTS-TCV full dose
|
—
|
0 Participants
|
—
|
0 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, saline
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, TCV full dose
|
—
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, iNTS-GMMA full dose
|
—
|
0 Participants
|
—
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Swelling, control
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, iNTS-TCV full dose
|
—
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the First Study Intervention Administration
Redness, saline
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57)Population: The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=43 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, iNTS-TCV full dose
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, saline
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, TCV full dose
|
—
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, iNTS-GMMA full dose
|
—
|
0 Participants
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Redness, control
|
—
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, iNTS-TCV full dose
|
—
|
0 Participants
|
—
|
0 Participants
|
35 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, saline
|
—
|
5 Participants
|
—
|
0 Participants
|
14 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, TCV full dose
|
—
|
0 Participants
|
—
|
24 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, iNTS-GMMA full dose
|
—
|
0 Participants
|
—
|
41 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Pain, control
|
—
|
9 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, iNTS-TCV full dose
|
—
|
0 Participants
|
—
|
0 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, saline
|
—
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, TCV full dose
|
—
|
0 Participants
|
—
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, iNTS-GMMA full dose
|
—
|
0 Participants
|
—
|
11 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Second Study Intervention Administration
Swelling, control
|
—
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169)Population: The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited administration site events included redness (Erythema), pain and swelling. Data for solicited administration site events is presented for each intervention administered in each arm group. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=14 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=38 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=42 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, iNTS-TCV full dose
|
—
|
0 Participants
|
—
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, saline
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, TCV full dose
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, iNTS-GMMA full dose
|
—
|
0 Participants
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Redness, control
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, iNTS-TCV full dose
|
—
|
0 Participants
|
—
|
0 Participants
|
32 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, saline
|
—
|
6 Participants
|
—
|
0 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, TCV full dose
|
—
|
0 Participants
|
—
|
19 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, iNTS-GMMA full dose
|
—
|
0 Participants
|
—
|
35 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Pain, control
|
—
|
8 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, iNTS-TCV full dose
|
—
|
0 Participants
|
—
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, saline
|
—
|
1 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, TCV full dose
|
—
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, iNTS-GMMA full dose
|
—
|
0 Participants
|
—
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Administration Site Events After the Third Study Intervention Administration
Swelling, control
|
—
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-first vaccination on Day 1)Population: The analysis was performed on the Solicited safety set, which included all participants who received first dose of the study intervention and who had solicited safety data in the 7 days following first intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature \>=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
Arthralgia
|
—
|
3 Participants
|
—
|
10 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
Fatigue
|
—
|
4 Participants
|
—
|
20 Participants
|
23 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
Headache
|
—
|
5 Participants
|
—
|
24 Participants
|
26 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
Myalgia
|
—
|
3 Participants
|
—
|
21 Participants
|
23 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Systemic Events After the First Study Intervention Administration
Fever
|
—
|
0 Participants
|
—
|
6 Participants
|
8 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-second vaccination on Day 57)Population: The analysis was performed on the Solicited safety set, which included all participants who received second dose of the study intervention and who had solicited safety data in the 7 days following second intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature \>=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=43 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration
Arthralgia
|
—
|
5 Participants
|
—
|
11 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration
Fatigue
|
—
|
4 Participants
|
—
|
24 Participants
|
18 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration
Headache
|
—
|
5 Participants
|
—
|
26 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration
Myalgia
|
—
|
5 Participants
|
—
|
20 Participants
|
18 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Solicited Systemic Events After the Second Study Intervention Administration
Fever
|
—
|
0 Participants
|
—
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post vaccination (day of administration and 6 subsequent days post-third vaccination on Day 169)Population: The analysis was performed on the Solicited safety set, which included all participants who received third dose of the study intervention and who had solicited safety data in the 7 days following third intervention. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain) and fever (pyrexia). Fever is defined as body temperature \>=38.0 degrees Celsius (°C). The preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=14 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=38 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=42 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
Arthralgia
|
—
|
3 Participants
|
—
|
15 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
Fatigue
|
—
|
2 Participants
|
—
|
18 Participants
|
18 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
Headache
|
—
|
2 Participants
|
—
|
23 Participants
|
21 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
Myalgia
|
—
|
4 Participants
|
—
|
18 Participants
|
17 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Any Solicited Systemic Events After the Third Study Intervention Administration
Fever
|
—
|
0 Participants
|
—
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 28 days post vaccination (day of administration and 27 subsequent days post-first vaccination on Day 1)Population: The analysis was performed on the unsolicited safety set, which included all participants who received the first dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any Unsolicited AE After the First Study Intervention Administration
|
—
|
8 Participants
|
—
|
24 Participants
|
21 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 28 days post vaccination (day of administration and 27 subsequent days post-second vaccination on Day 57)Population: The analysis was performed on the unsolicited safety set, which included all participants who received the second dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=43 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any Unsolicited AE After the Second Study Intervention Administration
|
—
|
3 Participants
|
—
|
17 Participants
|
13 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 28 days post vaccination (day of administration and 27 subsequent days post-third vaccination on Day 169)Population: The analysis was performed on the unsolicited safety set, which included all participants who received the third dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints. Only participants with data available at the mentioned timepoints were included in this analysis.
An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=14 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=38 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=42 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any Unsolicited AE After the Third Study Intervention Administration
|
—
|
1 Participants
|
—
|
12 Participants
|
13 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first study intervention administration (Day 1) up to 28 days after the third study intervention administration (Day 197)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any SAEs
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first study intervention administration (Day 1) up to 28 days after the third study intervention (Day 197)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Any AEs including SAEs that lead to withdrawal from the study are considered under this outcome measure. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first study intervention administration (Day 1) up to 28 days after the third study intervention (Day 197)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
AEs/SAEs that lead to withholding of the study intervention administration were considered under this outcome measure. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Any AEs/SAEs Leading to Withholding Further Study Intervention Administration
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 8 (7 days after the first study intervention administration) compared to Baseline (Day 1)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 8)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Within (baseline) - within (Day 8)
|
—
|
11 Participants
|
—
|
39 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Within (baseline) - above (Day 8)
|
—
|
2 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Above (baseline) - above (Day 8)
|
—
|
2 Participants
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Within (baseline) - within (Day 8)
|
—
|
13 Participants
|
—
|
43 Participants
|
43 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Above (baseline) - within (Day 8)
|
—
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Within (baseline) - within (Day 8)
|
—
|
15 Participants
|
—
|
44 Participants
|
39 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
1 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Within (baseline) - within (Day 8)
|
—
|
15 Participants
|
—
|
42 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Within (baseline) - within (Day 8)
|
—
|
11 Participants
|
—
|
32 Participants
|
35 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Above (baseline) - within (Day 8)
|
—
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Within (baseline) - above (Day 8)
|
—
|
1 Participants
|
—
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets · Above (baseline) - above (Day 8)
|
—
|
2 Participants
|
—
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Within (baseline) - within (Day 8)
|
—
|
14 Participants
|
—
|
41 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Above (baseline) - within (Day 8)
|
—
|
1 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
White Blood Cells [WBC] · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Below (baseline) - below (Day 8)
|
—
|
1 Participants
|
—
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
4 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Below (baseline) - within (Day 8)
|
—
|
3 Participants
|
—
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Within (baseline) - within (Day 8)
|
—
|
11 Participants
|
—
|
29 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood Urea Nitrogen · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Within (baseline) - within (Day 8)
|
—
|
15 Participants
|
—
|
44 Participants
|
45 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Within (baseline) - within (Day 8)
|
—
|
15 Participants
|
—
|
45 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Within (baseline) - within (Day 8)
|
—
|
13 Participants
|
—
|
35 Participants
|
36 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Above (baseline) - within (Day 8)
|
—
|
2 Participants
|
—
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Within (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Below (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Within (baseline) - within (Day 8)
|
—
|
12 Participants
|
—
|
43 Participants
|
37 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Above (baseline) - within (Day 8)
|
—
|
3 Participants
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Below (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Within (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST · Above (baseline) - above (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Below (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Within (baseline) - below (Day 8)
|
—
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Above (baseline) - below (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Below (baseline) - within (Day 8)
|
—
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Within (baseline) - within (Day 8)
|
—
|
13 Participants
|
—
|
41 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine · Above (baseline) - within (Day 8)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 64 (7 days after the second study intervention administration) compared to Baseline (Day 57)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 64 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 64)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=43 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Within (baseline) - within (Day 64)
|
—
|
12 Participants
|
—
|
35 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Within (baseline) - above (Day 64)
|
—
|
1 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
ALT · Above (baseline) - above (Day 64)
|
—
|
2 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Within (baseline) - within (Day 64)
|
—
|
11 Participants
|
—
|
39 Participants
|
40 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Within (baseline) - above (Day 64)
|
—
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
AST · Above (baseline) - above (Day 64)
|
—
|
3 Participants
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Below (baseline) - within (Day 64)
|
—
|
1 Participants
|
—
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Within (baseline) - within (Day 64)
|
—
|
14 Participants
|
—
|
34 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Creatinine · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Below (baseline) - below (Day 64)
|
—
|
4 Participants
|
—
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Within (baseline) - below (Day 64)
|
—
|
1 Participants
|
—
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Below (baseline) - within (Day 64)
|
—
|
2 Participants
|
—
|
2 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Within (baseline) - within (Day 64)
|
—
|
8 Participants
|
—
|
28 Participants
|
26 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Blood Urea Nitrogen · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
—
|
43 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Basophils · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
—
|
43 Participants
|
40 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Eosinophils · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Within (baseline) - within (Day 64)
|
—
|
13 Participants
|
—
|
37 Participants
|
37 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Hemoglobin · Above (baseline) - above (Day 64)
|
—
|
2 Participants
|
—
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
—
|
42 Participants
|
43 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Lymphocytes · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
—
|
41 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Monocytes · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
—
|
39 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Neutrophils · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Within (baseline) - within (Day 64)
|
—
|
12 Participants
|
—
|
35 Participants
|
34 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
Platelets · Above (baseline) - above (Day 64)
|
—
|
3 Participants
|
—
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Below (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Within (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Above (baseline) - below (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Below (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Within (baseline) - within (Day 64)
|
—
|
15 Participants
|
—
|
41 Participants
|
40 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Above (baseline) - within (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Below (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Within (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 64
White Blood Cells [WBC] · Above (baseline) - above (Day 64)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 176 (7 days after the third study intervention administration) compared to Baseline (Day 169)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 176)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=14 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=38 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=42 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Within (baseline) - within (Day 176)
|
—
|
14 Participants
|
—
|
34 Participants
|
37 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Within (baseline) - within (Day 176)
|
—
|
13 Participants
|
—
|
33 Participants
|
34 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST · Above (baseline) - above (Day 176)
|
—
|
1 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Below (baseline) - below (Day 176)
|
—
|
1 Participants
|
—
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Within (baseline) - within (Day 176)
|
—
|
13 Participants
|
—
|
33 Participants
|
35 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Below (baseline) - below (Day 176)
|
—
|
2 Participants
|
—
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Within (baseline) - below (Day 176)
|
—
|
5 Participants
|
—
|
5 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Below (baseline) - within (Day 176)
|
—
|
2 Participants
|
—
|
0 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Within (baseline) - within (Day 176)
|
—
|
5 Participants
|
—
|
28 Participants
|
23 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood Urea Nitrogen · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Within (baseline) - within (Day 176)
|
—
|
14 Participants
|
—
|
38 Participants
|
42 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Within (baseline) - within (Day 176)
|
—
|
14 Participants
|
—
|
38 Participants
|
42 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Within (baseline) - within (Day 176)
|
—
|
7 Participants
|
—
|
28 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Above (baseline) - within (Day 176)
|
—
|
3 Participants
|
—
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin · Above (baseline) - above (Day 176)
|
—
|
4 Participants
|
—
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Below (baseline) - within (Day 176)
|
—
|
14 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Within (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
36 Participants
|
40 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Within (baseline) - within (Day 176)
|
—
|
14 Participants
|
—
|
37 Participants
|
39 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Within (baseline) - within (Day 176)
|
—
|
14 Participants
|
—
|
35 Participants
|
40 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Within (baseline) - within (Day 176)
|
—
|
11 Participants
|
—
|
24 Participants
|
29 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Within (baseline) - above (Day 176)
|
—
|
1 Participants
|
—
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets · Above (baseline) - above (Day 176)
|
—
|
2 Participants
|
—
|
9 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Below (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Within (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Above (baseline) - below (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Below (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Within (baseline) - within (Day 176)
|
—
|
14 Participants
|
—
|
36 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Above (baseline) - within (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Below (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Within (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
White Blood Cells [WBC] · Above (baseline) - above (Day 176)
|
—
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 29 (28 days after the first study intervention administration) compared to Baseline (Day 1)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 1 (baseline) and Day 29 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 29)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Within (baseline) - within (Day 29)
|
—
|
15 Participants
|
—
|
44 Participants
|
45 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Within (baseline) - within (Day 29)
|
—
|
12 Participants
|
—
|
31 Participants
|
35 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Above (baseline) - within (Day 29)
|
—
|
2 Participants
|
—
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Within (baseline) - above (Day 29)
|
—
|
1 Participants
|
—
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
ALT · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Within (baseline) - within (Day 29)
|
—
|
11 Participants
|
—
|
41 Participants
|
39 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Above (baseline) - within (Day 29)
|
—
|
1 Participants
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Within (baseline) - above (Day 29)
|
—
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
AST · Above (baseline) - above (Day 29)
|
—
|
2 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Below (baseline) - below (Day 29)
|
—
|
1 Participants
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Within (baseline) - within (Day 29)
|
—
|
14 Participants
|
—
|
42 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Creatinine · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Below (baseline) - below (Day 29)
|
—
|
3 Participants
|
—
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Within (baseline) - below (Day 29)
|
—
|
3 Participants
|
—
|
6 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Below (baseline) - within (Day 29)
|
—
|
1 Participants
|
—
|
9 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Within (baseline) - within (Day 29)
|
—
|
8 Participants
|
—
|
27 Participants
|
25 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Blood Urea Nitrogen · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Basophils · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Within (baseline) - within (Day 29)
|
—
|
15 Participants
|
—
|
45 Participants
|
45 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Eosinophils · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Within (baseline) - within (Day 29)
|
—
|
12 Participants
|
—
|
39 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Within (baseline) - above (Day 29)
|
—
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Hemoglobin · Above (baseline) - above (Day 29)
|
—
|
2 Participants
|
—
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Within (baseline) - within (Day 29)
|
—
|
13 Participants
|
—
|
44 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Above (baseline) - within (Day 29)
|
—
|
2 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Lymphocytes · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Within (baseline) - within (Day 29)
|
—
|
15 Participants
|
—
|
45 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Monocytes · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Within (baseline) - within (Day 29)
|
—
|
15 Participants
|
—
|
43 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Neutrophils · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Within (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Within (baseline) - within (Day 29)
|
—
|
12 Participants
|
—
|
36 Participants
|
39 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Above (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
Platelets · Above (baseline) - above (Day 29)
|
—
|
3 Participants
|
—
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Below (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Within (baseline) - below (Day 29)
|
—
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Above (baseline) - below (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Below (baseline) - within (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Within (baseline) - within (Day 29)
|
—
|
13 Participants
|
—
|
43 Participants
|
43 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Above (baseline) - within (Day 29)
|
—
|
1 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Below (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Within (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 29
White Blood Cells [WBC] · Above (baseline) - above (Day 29)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 85 (28 days after the second study intervention administration) compared to Baseline (Day 57)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 57 (baseline) and Day 85 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 85)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=43 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Within (baseline) - within (Day 85)
|
—
|
14 Participants
|
—
|
41 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Above (baseline) - within (Day 85)
|
—
|
1 Participants
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Within (baseline) - within (Day 85)
|
—
|
13 Participants
|
—
|
33 Participants
|
39 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Above (baseline) - within (Day 85)
|
—
|
2 Participants
|
—
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
ALT · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Within (baseline) - within (Day 85)
|
—
|
12 Participants
|
—
|
37 Participants
|
33 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Above (baseline) - within (Day 85)
|
—
|
1 Participants
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Platelets · Above (baseline) - above (Day 85)
|
—
|
2 Participants
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Within (baseline) - within (Day 85)
|
—
|
12 Participants
|
—
|
36 Participants
|
40 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Above (baseline) - within (Day 85)
|
—
|
1 Participants
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
AST · Above (baseline) - above (Day 85)
|
—
|
2 Participants
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Below (baseline) - below (Day 85)
|
—
|
1 Participants
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
—
|
43 Participants
|
42 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Within (baseline) - below (Day 85)
|
—
|
1 Participants
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Within (baseline) - within (Day 85)
|
—
|
13 Participants
|
—
|
35 Participants
|
39 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Creatinine · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Below (baseline) - below (Day 85)
|
—
|
3 Participants
|
—
|
4 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Within (baseline) - below (Day 85)
|
—
|
1 Participants
|
—
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Below (baseline) - within (Day 85)
|
—
|
3 Participants
|
—
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Within (baseline) - within (Day 85)
|
—
|
8 Participants
|
—
|
30 Participants
|
27 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Blood Urea Nitrogen · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
—
|
43 Participants
|
43 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Basophils · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
—
|
43 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Eosinophils · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
White Blood Cells [WBC] · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Within (baseline) - within (Day 85)
|
—
|
12 Participants
|
—
|
38 Participants
|
36 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Within (baseline) - above (Day 85)
|
—
|
1 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Hemoglobin · Above (baseline) - above (Day 85)
|
—
|
2 Participants
|
—
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
—
|
42 Participants
|
43 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Lymphocytes · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Below (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Within (baseline) - within (Day 85)
|
—
|
15 Participants
|
—
|
42 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Above (baseline) - within (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Below (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Within (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Monocytes · Above (baseline) - above (Day 85)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Below (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Within (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 85
Neutrophils · Above (baseline) - below (Day 85)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 197 (28 days after the third study intervention administration) compared to Baseline (Day 169)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Assessed hepatic laboratory parameters included ALT and AST, and renal laboratory parameters included creatinine and urea/blood urea nitrogen. Hematological laboratory parameters included basophils, eosinophils, hemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBCs). Categories reported when comparing Day 169 (baseline) and Day 197 hematological, renal and hepatic laboratory results are defined as follows: \<range\> (at baseline) - \<range\> (at timing) (e.g. Within (Baseline) - Within (Day 197)) where range is being classified as below, within or above the normal range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=14 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=38 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=42 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Within (baseline) - within (Day 197)
|
—
|
13 Participants
|
—
|
30 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Within (baseline) - above (Day 197)
|
—
|
1 Participants
|
—
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
ALT · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Within (baseline) - within (Day 197)
|
—
|
12 Participants
|
—
|
32 Participants
|
36 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Within (baseline) - above (Day 197)
|
—
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
AST · Above (baseline) - above (Day 197)
|
—
|
1 Participants
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Below (baseline) - below (Day 197)
|
—
|
1 Participants
|
—
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Within (baseline) - within (Day 197)
|
—
|
13 Participants
|
—
|
33 Participants
|
35 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Creatinine · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Below (baseline) - below (Day 197)
|
—
|
3 Participants
|
—
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Within (baseline) - below (Day 197)
|
—
|
1 Participants
|
—
|
5 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Below (baseline) - within (Day 197)
|
—
|
1 Participants
|
—
|
2 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Within (baseline) - within (Day 197)
|
—
|
9 Participants
|
—
|
28 Participants
|
21 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Blood Urea Nitrogen · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Within (baseline) - within (Day 197)
|
—
|
14 Participants
|
—
|
38 Participants
|
42 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Basophils · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Within (baseline) - within (Day 197)
|
—
|
14 Participants
|
—
|
38 Participants
|
42 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Eosinophils · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Within (baseline) - within (Day 197)
|
—
|
6 Participants
|
—
|
29 Participants
|
28 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Above (baseline) - within (Day 197)
|
—
|
3 Participants
|
—
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Within (baseline) - above (Day 197)
|
—
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Hemoglobin · Above (baseline) - above (Day 197)
|
—
|
4 Participants
|
—
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Within (baseline) - within (Day 197)
|
—
|
14 Participants
|
—
|
37 Participants
|
39 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Lymphocytes · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Within (baseline) - within (Day 197)
|
—
|
14 Participants
|
—
|
37 Participants
|
39 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Monocytes · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Within (baseline) - within (Day 197)
|
—
|
14 Participants
|
—
|
33 Participants
|
42 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Neutrophils · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Within (baseline) - within (Day 197)
|
—
|
11 Participants
|
—
|
28 Participants
|
33 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Within (baseline) - above (Day 197)
|
—
|
1 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
Platelets · Above (baseline) - above (Day 197)
|
—
|
2 Participants
|
—
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells [WBC] · Below (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells [WBC] · Within (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells [WBC] · Above (baseline) - below (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells [WBC] · Below (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells [WBC] · Within (baseline) - within (Day 197)
|
—
|
14 Participants
|
—
|
36 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells [WBC] · Above (baseline) - within (Day 197)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells [WBC] · Below (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells [WBC] · Within (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 197
White Blood Cells [WBC] · Above (baseline) - above (Day 197)
|
—
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 28 days after the third study intervention administration (Day 197) up to study end (Day 337)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
n=15 Participants
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1 and Stage 2: Number of Participants With Any SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From 28 days after the third study intervention administration (Day 197) up to study end (Day 337)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
Any AEs including SAEs that lead to withdrawal from the study are considered under this outcome measure. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
n=45 Participants
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
n=15 Participants
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1 and Stage 2: Number of Participants With Any AEs/SAEs Leading to Withdrawal From the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration)Population: The analysis was performed on the Per Protocol Set (PPS), that included all eligible participants who received all doses as per protocol, had immunogenicity results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-Vi antigen (Ag) total IgG GMCs were assessed. Blood samples were collected at specified timepoint for each component as measured by Enzyme-Linked Immunosorbent Assay (ELISA). The lower limit of quantification (LLOQ) for antibody concentrations was \>=2.2 microgram per milliliter (µg/mL). In case the measured antibody concentration fell below 2.2 µg/mL, a value of half the LLOQ value was imputed.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG
Anti-Vi Ag total IgG, Day 1
|
—
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs at Day 1 when all participants were below LLOQ.
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs at Day 1 when all participants were below LLOQ.
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs at Day 1 when all participants were below LLOQ.
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs at Day 1 when all participants were below LLOQ (lower limit of quantification).
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs at Day 1 when all participants were below LLOQ.
|
—
|
—
|
|
Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG
Anti-Vi Ag total IgG, Day 29
|
—
|
43.55 microgram per milliliter (µg/mL)
Interval 18.51 to 102.49
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs for this group as all participants were below LLOQ.
|
68.87 microgram per milliliter (µg/mL)
Interval 1.73 to 2741.0
|
30.29 microgram per milliliter (µg/mL)
Interval 13.5 to 67.95
|
66.48 microgram per milliliter (µg/mL)
Interval 37.31 to 118.46
|
—
|
—
|
|
Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG
Anti-Vi Ag total IgG, Day 57
|
—
|
25.99 microgram per milliliter (µg/mL)
Interval 9.86 to 68.5
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs for this group as all participants were below LLOQ.
|
53.95 microgram per milliliter (µg/mL)
Interval 2.37 to 1226.99
|
23.28 microgram per milliliter (µg/mL)
Interval 16.49 to 32.89
|
51.01 microgram per milliliter (µg/mL)
Interval 27.55 to 94.46
|
—
|
—
|
|
Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG
Anti-Vi Ag total IgG, Day 85
|
—
|
34.02 microgram per milliliter (µg/mL)
Interval 16.67 to 69.44
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs for this group as all participants were below LLOQ.
|
51.71 microgram per milliliter (µg/mL)
Interval 3.42 to 781.48
|
30.52 microgram per milliliter (µg/mL)
Interval 14.75 to 63.13
|
51.65 microgram per milliliter (µg/mL)
Interval 31.18 to 85.55
|
—
|
—
|
|
Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG
Anti-Vi Ag total IgG, Day 169
|
—
|
15.76 microgram per milliliter (µg/mL)
Interval 8.14 to 30.48
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs for this group as all participants were below LLOQ.
|
14.11 microgram per milliliter (µg/mL)
Interval 0.22 to 10265.73
|
13.61 microgram per milliliter (µg/mL)
Interval 4.28 to 43.23
|
20.69 microgram per milliliter (µg/mL)
Interval 12.68 to 33.76
|
—
|
—
|
|
Stage 1: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Immunoglobulin G (IgG) in Participants and Between Group Ratios for Anti-Vi Antigen (Ag) Total IgG
Anti-Vi Ag total IgG, Day 197
|
—
|
31.84 microgram per milliliter (µg/mL)
Interval 16.24 to 62.43
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs for this group as all participants were below LLOQ.
|
17.43 microgram per milliliter (µg/mL)
Interval 0.01 to 26224.47
|
20.19 microgram per milliliter (µg/mL)
Interval 1.48 to 275.08
|
35.24 microgram per milliliter (µg/mL)
Interval 23.65 to 52.49
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration)Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG GMCs were assessed. Blood samples were collected at specified timepoint for each component as measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=4 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 57
|
—
|
1075.57 ELISA units per milliliter (EU/mL)
Interval 466.12 to 2481.85
|
58.38 ELISA units per milliliter (EU/mL)
Interval 16.45 to 207.16
|
139.78 ELISA units per milliliter (EU/mL)
Interval 5.42 to 3604.75
|
423.33 ELISA units per milliliter (EU/mL)
Interval 81.46 to 2200.08
|
1203.79 ELISA units per milliliter (EU/mL)
Interval 589.73 to 2457.26
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 1
|
—
|
94.10 ELISA units per milliliter (EU/mL)
Interval 34.63 to 255.69
|
52.23 ELISA units per milliliter (EU/mL)
Interval 19.31 to 141.31
|
49.45 ELISA units per milliliter (EU/mL)
Interval 0.68 to 3599.82
|
20.25 ELISA units per milliliter (EU/mL)
Interval 3.23 to 126.95
|
124.02 ELISA units per milliliter (EU/mL)
Interval 54.83 to 280.53
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 29
|
—
|
1426.07 ELISA units per milliliter (EU/mL)
Interval 777.69 to 2615.03
|
52.86 ELISA units per milliliter (EU/mL)
Interval 19.93 to 140.2
|
169.25 ELISA units per milliliter (EU/mL)
Interval 4.35 to 6586.95
|
494.50 ELISA units per milliliter (EU/mL)
Interval 80.16 to 3050.49
|
1505.55 ELISA units per milliliter (EU/mL)
Interval 815.65 to 2778.99
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 85
|
—
|
1129.27 ELISA units per milliliter (EU/mL)
Interval 497.2 to 2564.86
|
68.07 ELISA units per milliliter (EU/mL)
Interval 17.22 to 269.09
|
243.42 ELISA units per milliliter (EU/mL)
Interval 3.18 to 18606.83
|
410.29 ELISA units per milliliter (EU/mL)
Interval 87.67 to 1920.18
|
1478.01 ELISA units per milliliter (EU/mL)
Interval 804.57 to 2715.11
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 169
|
—
|
703.74 ELISA units per milliliter (EU/mL)
Interval 296.98 to 1667.63
|
75.80 ELISA units per milliliter (EU/mL)
Interval 21.92 to 262.14
|
109.20 ELISA units per milliliter (EU/mL)
Interval 0.0 to 1040000000000.0
|
272.19 ELISA units per milliliter (EU/mL)
Interval 43.1 to 1718.88
|
951.71 ELISA units per milliliter (EU/mL)
Interval 498.59 to 1816.63
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 197
|
—
|
1005.05 ELISA units per milliliter (EU/mL)
Interval 445.54 to 2267.2
|
73.43 ELISA units per milliliter (EU/mL)
Interval 21.98 to 245.25
|
163.07 ELISA units per milliliter (EU/mL)
Interval 0.0 to 1190000000000.0
|
249.07 ELISA units per milliliter (EU/mL)
Interval 21.83 to 2842.34
|
1176.88 ELISA units per milliliter (EU/mL)
Interval 719.47 to 1925.1
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 1
|
—
|
125.64 ELISA units per milliliter (EU/mL)
Interval 47.39 to 333.09
|
57.08 ELISA units per milliliter (EU/mL)
Interval 21.97 to 148.25
|
42.77 ELISA units per milliliter (EU/mL)
Interval 0.32 to 5784.66
|
67.85 ELISA units per milliliter (EU/mL)
Interval 6.04 to 761.69
|
115.74 ELISA units per milliliter (EU/mL)
Interval 46.32 to 289.22
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 29
|
—
|
1648.46 ELISA units per milliliter (EU/mL)
Interval 1023.81 to 2654.22
|
56.62 ELISA units per milliliter (EU/mL)
Interval 21.49 to 149.13
|
169.46 ELISA units per milliliter (EU/mL)
Interval 0.32 to 90734.61
|
920.64 ELISA units per milliliter (EU/mL)
Interval 104.11 to 8141.15
|
1387.16 ELISA units per milliliter (EU/mL)
Interval 587.94 to 3272.77
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 57
|
—
|
1454.26 ELISA units per milliliter (EU/mL)
Interval 801.81 to 2637.64
|
65.49 ELISA units per milliliter (EU/mL)
Interval 18.13 to 236.58
|
141.59 ELISA units per milliliter (EU/mL)
Interval 0.42 to 47560.41
|
832.83 ELISA units per milliliter (EU/mL)
Interval 110.24 to 6291.99
|
1076.32 ELISA units per milliliter (EU/mL)
Interval 400.41 to 2893.21
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 85
|
—
|
1436.56 ELISA units per milliliter (EU/mL)
Interval 779.81 to 2646.42
|
79.79 ELISA units per milliliter (EU/mL)
Interval 18.55 to 343.09
|
209.03 ELISA units per milliliter (EU/mL)
Interval 0.88 to 49901.51
|
882.68 ELISA units per milliliter (EU/mL)
Interval 132.51 to 5879.62
|
1267.65 ELISA units per milliliter (EU/mL)
Interval 511.67 to 3140.56
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 169
|
—
|
903.37 ELISA units per milliliter (EU/mL)
Interval 487.13 to 1675.3
|
75.96 ELISA units per milliliter (EU/mL)
Interval 20.72 to 278.48
|
42.14 ELISA units per milliliter (EU/mL)
Interval 0.01 to 162000.0
|
557.81 ELISA units per milliliter (EU/mL)
Interval 78.28 to 3975.01
|
729.86 ELISA units per milliliter (EU/mL)
Interval 255.41 to 2085.64
|
—
|
—
|
|
Stage 1: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 197
|
—
|
1168.56 ELISA units per milliliter (EU/mL)
Interval 642.31 to 2125.99
|
73.74 ELISA units per milliliter (EU/mL)
Interval 20.17 to 269.56
|
81.17 ELISA units per milliliter (EU/mL)
Interval 0.87 to 7578.12
|
451.36 ELISA units per milliliter (EU/mL)
Interval 22.54 to 9036.65
|
855.62 ELISA units per milliliter (EU/mL)
Interval 356.65 to 2052.67
|
—
|
—
|
SECONDARY outcome
Timeframe: At 28 days after each study intervention administration compared to each study intervention administration baseline (Day 29 versus Day 1, Day 85 versus Day 57 and Day 197 versus Day 169)Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-Vi antigen (Ag) total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG within-participant GMRs were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=3 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-Vi Ag total IgG, Day 29
|
—
|
39.60 Ratio
Interval 16.83 to 93.18
|
1.00 Ratio
Interval 1.0 to 1.0
|
62.61 Ratio
Interval 1.57 to 2491.81
|
27.53 Ratio
Interval 12.27 to 61.77
|
60.44 Ratio
Interval 33.92 to 107.69
|
—
|
—
|
|
Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-Vi Ag total IgG, Day 85
|
—
|
1.31 Ratio
Interval 0.87 to 1.97
|
1.00 Ratio
Interval 1.0 to 1.0
|
0.96 Ratio
Interval 0.47 to 1.96
|
1.31 Ratio
Interval 0.8 to 2.14
|
1.01 Ratio
Interval 0.78 to 1.31
|
—
|
—
|
|
Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-Vi Ag total IgG, Day 197
|
—
|
1.99 Ratio
Interval 1.38 to 2.89
|
1.00 Ratio
Interval 1.0 to 1.0
|
1.24 Ratio
Interval 0.6 to 2.55
|
1.96 Ratio
Interval 0.49 to 7.78
|
1.70 Ratio
Interval 1.38 to 2.1
|
—
|
—
|
|
Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Typhimurium OAg IgG. Day 29
|
—
|
15.15 Ratio
Interval 5.57 to 41.26
|
1.01 Ratio
Interval 0.94 to 1.09
|
3.42 Ratio
Interval 0.48 to 24.2
|
24.42 Ratio
Interval 11.3 to 52.75
|
12.14 Ratio
Interval 6.83 to 21.58
|
—
|
—
|
|
Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Typhimurium OAg IgG. Day 85
|
—
|
1.05 Ratio
Interval 0.86 to 1.28
|
1.17 Ratio
Interval 0.97 to 1.4
|
1.74 Ratio
Interval 0.44 to 6.87
|
0.97 Ratio
Interval 0.63 to 1.5
|
1.23 Ratio
Interval 0.89 to 1.69
|
—
|
—
|
|
Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Typhimurium OAg IgG. Day 197
|
—
|
1.20 Ratio
Interval 1.01 to 1.44
|
0.97 Ratio
Interval 0.9 to 1.04
|
1.49 Ratio
Interval 1.14 to 1.95
|
1.47 Ratio
Interval 0.8 to 2.71
|
1.24 Ratio
Interval 0.93 to 1.65
|
—
|
—
|
|
Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Enteritidis OAg IgG Day 29
|
—
|
13.12 Ratio
Interval 5.41 to 31.8
|
0.99 Ratio
Interval 0.93 to 1.06
|
3.96 Ratio
Interval 0.67 to 23.52
|
13.57 Ratio
Interval 3.76 to 48.93
|
11.98 Ratio
Interval 6.57 to 21.86
|
—
|
—
|
|
Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Enteritidis OAg IgG Day 85
|
—
|
0.99 Ratio
Interval 0.86 to 1.14
|
1.22 Ratio
Interval 0.97 to 1.53
|
1.48 Ratio
Interval 0.59 to 3.67
|
1.06 Ratio
Interval 0.9 to 1.24
|
1.18 Ratio
Interval 0.82 to 1.69
|
—
|
—
|
|
Stage 1: Geometric Mean Ratios (GMRs) for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Enteritidis OAg IgG Day 197
|
—
|
1.15 Ratio
Interval 1.03 to 1.28
|
0.97 Ratio
Interval 0.95 to 0.99
|
1.93 Ratio
Interval 0.05 to 79.54
|
1.29 Ratio
Interval 0.68 to 2.45
|
1.17 Ratio
Interval 0.92 to 1.49
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 29, 85, and 197 (28 days after each study intervention administration) compared to Day 1 (first study intervention administration)Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-Vi Ag total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG antibody concentrations were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=3 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-Vi Ag IgG, Day 197
|
—
|
10 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Typhimurium OAg IgG, Day 29
|
—
|
13 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
15 Participants
|
—
|
—
|
|
Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Typhimurium OAg IgG, Day 85
|
—
|
8 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Typhimurium OAg IgG, Day 197
|
—
|
6 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
—
|
—
|
|
Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Enteritidis OAg IgG, Day 29
|
—
|
11 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
12 Participants
|
—
|
—
|
|
Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Enteritidis OAg IgG, Day 85
|
—
|
7 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
11 Participants
|
—
|
—
|
|
Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Enteritidis OAg IgG, Day 197
|
—
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
—
|
—
|
|
Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-Vi Ag IgG, Day 29
|
—
|
13 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-Vi Ag IgG, Day 85
|
—
|
10 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration)Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at specified timepoint for each component as measured by ELISA.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 Participants
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=3 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 Participants
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 1 (pre-Dose 1)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 29
|
—
|
14 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
16 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 57 (pre-Dose 2)
|
—
|
9 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 85
|
—
|
12 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 169 (pre-Dose 3)
|
—
|
11 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
14 Participants
|
—
|
—
|
|
Stage 1: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 197
|
—
|
11 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
14 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration)Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-Vi Ag total IgG GMCs and between group ratios were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=44 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG
Anti-Vi Ag total IgG, Day 57
|
—
|
1.60 µg/mL
Interval 1.01 to 2.53
|
—
|
104.38 µg/mL
Interval 69.77 to 156.16
|
96.93 µg/mL
Interval 67.0 to 140.23
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG
Anti-Vi Ag total IgG, Day 85
|
—
|
1.65 µg/mL
Interval 1.08 to 2.52
|
—
|
101.92 µg/mL
Interval 72.02 to 144.24
|
96.94 µg/mL
Interval 72.03 to 130.48
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG
Anti-Vi Ag total IgG, Day 169
|
—
|
1.88 µg/mL
Interval 1.18 to 2.99
|
—
|
53.65 µg/mL
Interval 34.97 to 82.32
|
41.83 µg/mL
Interval 29.43 to 59.46
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG
Anti-Vi Ag total IgG, Day 197
|
—
|
18.60 µg/mL
Interval 8.28 to 41.76
|
—
|
69.82 µg/mL
Interval 50.09 to 97.3
|
65.43 µg/mL
Interval 51.01 to 83.92
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG
Anti-Vi Ag total IgG, Day 1
|
—
|
1.56 µg/mL
Interval 1.11 to 2.19
|
—
|
1.38 µg/mL
Interval 1.13 to 1.69
|
1.43 µg/mL
Interval 1.2 to 1.7
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-Vi Ag Total IgG
Anti-Vi Ag total IgG, Day 29
|
—
|
1.55 µg/mL
Interval 1.04 to 2.33
|
—
|
161.68 µg/mL
Interval 107.38 to 243.46
|
148.98 µg/mL
Interval 103.31 to 214.83
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 1, 57, and 169 (before each study intervention administration) and at Days 29, 85, and 197 (28 days after each study intervention administration)Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-S. Typhimurium OAg total IgG and Anti-S. Enteritidis OAg total IgG GMCs and between group ratios were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=44 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 57
|
—
|
483.46 EU/mL
Interval 329.52 to 709.32
|
—
|
1794.69 EU/mL
Interval 1419.63 to 2268.85
|
1159.50 EU/mL
Interval 806.72 to 1666.56
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 85
|
—
|
545.05 EU/mL
Interval 355.58 to 835.46
|
—
|
1765.79 EU/mL
Interval 1395.81 to 2233.85
|
1102.67 EU/mL
Interval 771.64 to 1575.7
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 1
|
—
|
392.99 EU/mL
Interval 273.9 to 563.87
|
—
|
490.94 EU/mL
Interval 378.78 to 636.31
|
246.02 EU/mL
Interval 167.63 to 361.07
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 29
|
—
|
446.22 EU/mL
Interval 290.49 to 685.45
|
—
|
2585.81 EU/mL
Interval 2024.74 to 3302.35
|
1591.68 EU/mL
Interval 1117.07 to 2267.94
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 169
|
—
|
565.73 EU/mL
Interval 349.09 to 916.82
|
—
|
1248.95 EU/mL
Interval 979.1 to 1593.18
|
870.80 EU/mL
Interval 552.07 to 1373.57
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Typhimurium OAg IgG, Day 197
|
—
|
542.87 EU/mL
Interval 340.01 to 866.75
|
—
|
1748.80 EU/mL
Interval 1359.79 to 2249.09
|
992.82 EU/mL
Interval 645.92 to 1526.03
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 1
|
—
|
394.19 EU/mL
Interval 193.54 to 802.88
|
—
|
376.17 EU/mL
Interval 270.58 to 522.95
|
363.08 EU/mL
Interval 228.49 to 576.96
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 29
|
—
|
457.08 EU/mL
Interval 209.54 to 997.03
|
—
|
2295.38 EU/mL
Interval 1642.33 to 3208.1
|
1884.94 EU/mL
Interval 1272.38 to 2792.41
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 57
|
—
|
470.88 EU/mL
Interval 214.12 to 1035.51
|
—
|
1581.75 EU/mL
Interval 1153.18 to 2169.6
|
1527.50 EU/mL
Interval 1030.99 to 2263.13
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 85
|
—
|
456.04 EU/mL
Interval 215.01 to 967.26
|
—
|
1555.91 EU/mL
Interval 1134.43 to 2133.97
|
1604.28 EU/mL
Interval 1109.24 to 2320.23
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 169
|
—
|
408.69 EU/mL
Interval 190.4 to 877.23
|
—
|
1015.74 EU/mL
Interval 727.61 to 1417.95
|
946.93 EU/mL
Interval 646.79 to 1386.34
|
—
|
—
|
—
|
|
Stage 2: GMCs of Anti-serotype Specific IgG in Participants and Between Group Ratios for Anti-S. Typhimurium OAg Total IgG and Anti-S. Enteritidis OAg Total IgG
Anti-S.Enteritidis OAg IgG, Day 197
|
—
|
423.08 EU/mL
Interval 213.16 to 839.75
|
—
|
1327.68 EU/mL
Interval 972.03 to 1813.45
|
1093.84 EU/mL
Interval 757.63 to 1579.27
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 28 days after each study intervention administration compared to each study intervention administration baseline (Day 29 versus Day 1, Day 85 versus Day 57 and Day 197 versus Day 169)Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-Vi antigen (Ag) total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG within-participant GMRs were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=44 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-Vi Ag total IgG, Day 29
|
—
|
1.00 Ratio
Interval 0.74 to 1.34
|
—
|
116.84 Ratio
Interval 79.82 to 171.01
|
104.51 Ratio
Interval 77.39 to 141.12
|
—
|
—
|
—
|
|
Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-Vi Ag total IgG, Day 85
|
—
|
1.03 Ratio
Interval 0.92 to 1.16
|
—
|
0.91 Ratio
Interval 0.83 to 1.0
|
1.05 Ratio
Interval 0.92 to 1.2
|
—
|
—
|
—
|
|
Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-Vi Ag total IgG, Day 197
|
—
|
9.89 Ratio
Interval 5.14 to 19.04
|
—
|
1.37 Ratio
Interval 1.1 to 1.69
|
1.56 Ratio
Interval 1.3 to 1.88
|
—
|
—
|
—
|
|
Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Typhimurium OAg IgG. Day 29
|
—
|
1.14 Ratio
Interval 0.83 to 1.55
|
—
|
5.27 Ratio
Interval 4.12 to 6.73
|
6.47 Ratio
Interval 4.97 to 8.42
|
—
|
—
|
—
|
|
Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Typhimurium OAg IgG. Day 85
|
—
|
1.13 Ratio
Interval 0.89 to 1.42
|
—
|
0.97 Ratio
Interval 0.89 to 1.06
|
1.00 Ratio
Interval 0.92 to 1.1
|
—
|
—
|
—
|
|
Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Typhimurium OAg IgG. Day 197
|
—
|
0.96 Ratio
Interval 0.81 to 1.14
|
—
|
1.41 Ratio
Interval 1.18 to 1.7
|
1.14 Ratio
Interval 1.04 to 1.25
|
—
|
—
|
—
|
|
Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Enteritidis OAg IgG Day 29
|
—
|
1.16 Ratio
Interval 0.82 to 1.65
|
—
|
6.10 Ratio
Interval 4.47 to 8.33
|
5.19 Ratio
Interval 3.44 to 7.83
|
—
|
—
|
—
|
|
Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Enteritidis OAg IgG Day 85
|
—
|
0.97 Ratio
Interval 0.83 to 1.13
|
—
|
0.99 Ratio
Interval 0.9 to 1.1
|
1.04 Ratio
Interval 0.94 to 1.15
|
—
|
—
|
—
|
|
Stage 2: GMRs for Anti-serotype Specific Immunoglobulin G (IgG) Concentrations
Anti-S.Enteritidis OAg IgG Day 197
|
—
|
1.04 Ratio
Interval 0.86 to 1.25
|
—
|
1.34 Ratio
Interval 1.11 to 1.62
|
1.16 Ratio
Interval 1.0 to 1.34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 29, 85, and 197 (28 days after each study intervention administration) compared to Day 1 (first study intervention administration baseline)Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-Vi Ag total IgG, Anti-S. Typhimurium OAg total IgG, Anti-S. Enteritidis OAg total IgG antibody concentrations were assessed. Blood samples were collected at specified timepoint for each component as measured by ELISA.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=44 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Typhimurium OAg IgG, Day 29
|
—
|
1 Participants
|
—
|
27 Participants
|
33 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Typhimurium OAg IgG, Day 85
|
—
|
1 Participants
|
—
|
16 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Typhimurium OAg IgG, 197
|
—
|
1 Participants
|
—
|
16 Participants
|
23 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Enteritidis OAg IgG, 29
|
—
|
1 Participants
|
—
|
27 Participants
|
23 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Enteritidis OAg IgG, Day 85
|
—
|
2 Participants
|
—
|
18 Participants
|
21 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-S.Enteritidis OAg IgG, Day 197
|
—
|
0 Participants
|
—
|
16 Participants
|
17 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-Vi Ag IgG, Day 85
|
—
|
1 Participants
|
—
|
42 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-Vi Ag IgG, Day 197
|
—
|
9 Participants
|
—
|
37 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants Achieving at Least a 4 Fold Rise in Anti Serotype Specific Immunoglobulin G (IgG) Antibody Concentration for Each Antigen (Ag)
Anti-Vi Ag IgG, Day 29
|
—
|
0 Participants
|
—
|
43 Participants
|
44 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration)Population: The analysis was performed on the PPS. Only participants with data available at the mentioned timepoints were included in this analysis.
Blood samples were collected at specified timepoint for each component as measured by ELISA.
Outcome measures
| Measure |
Stage 2: iNTS-GMMA + TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=15 Participants
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=44 Participants
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=45 Participants
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL
Day 1
|
—
|
3 Participants
|
—
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL
Day 29
|
—
|
3 Participants
|
—
|
44 Participants
|
45 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL
Day 57
|
—
|
3 Participants
|
—
|
44 Participants
|
45 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL
Day 85
|
—
|
3 Participants
|
—
|
43 Participants
|
44 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL
Day 169
|
—
|
3 Participants
|
—
|
37 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Stage 2: Number of Participants With Anti-Vi Ag IgG Antibody Concentrations >= 4.3 µg/mL
Day 197
|
—
|
12 Participants
|
—
|
37 Participants
|
41 Participants
|
—
|
—
|
—
|
Adverse Events
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Stage 1: iNTS-TCV Full Dose Group
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Stage 1: iNTS-GMMA + TCV Full Dose Group
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Stage 1: Placebo Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Stage 2: iNTS-TCV Full Dose Group
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Stage 2: iNTS-GMMA + TCV Full Dose Group
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
Stage 2: Control Group
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 participants at risk
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group
n=4 participants at risk
European participants were randomized to receive 3 doses of iNTS-GMMA low dose vaccine and 3 doses of TCV low dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 participants at risk
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 participants at risk
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 participants at risk
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
n=45 participants at risk
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 participants at risk
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
n=15 participants at risk
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Malaria
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
Other adverse events
| Measure |
Stage 1: Invasive Nontyphoidal Salmonella (iNTS)-Typhoid Conjugate Vaccine (TCV) Low Dose Group
n=4 participants at risk
European participants were randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-Generalized Modules for Membrane Antigens (GMMA) + TCV Low Dose Group
n=4 participants at risk
European participants were randomized to receive 3 doses of iNTS-GMMA low dose vaccine and 3 doses of TCV low dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-TCV Full Dose Group
n=16 participants at risk
European participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: iNTS-GMMA + TCV Full Dose Group
n=16 participants at risk
European participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 1: Placebo Group
n=10 participants at risk
European participants were randomized to receive 3 doses of Placebo and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-TCV Full Dose Group
n=45 participants at risk
African participants were randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: iNTS-GMMA + TCV Full Dose Group
n=45 participants at risk
African participants were randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose intramuscularly, in different arms, on Day 1, Day 57 and Day 169.
|
Stage 2: Control Group
n=15 participants at risk
African participants were randomized to receive MENVEO as comparator and 1 dose of saline on Day 1, BOOSTRIX as comparator and 1 dose of saline on Day 57 and TYPHIM VI as comparator and 1 dose of saline on Day 169.
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Chalazion
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
25.0%
1/4 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Administration site erythema
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
50.0%
8/16 • Number of events 13 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
43.8%
7/16 • Number of events 12 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
13.3%
6/45 • Number of events 7 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
22.2%
10/45 • Number of events 19 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Administration site pain
|
100.0%
4/4 • Number of events 15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
100.0%
4/4 • Number of events 13 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
100.0%
16/16 • Number of events 44 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
100.0%
16/16 • Number of events 54 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
80.0%
8/10 • Number of events 19 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
88.9%
40/45 • Number of events 145 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
100.0%
45/45 • Number of events 180 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
86.7%
13/15 • Number of events 39 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Administration site pruritus
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Administration site swelling
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
37.5%
6/16 • Number of events 8 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
18.8%
3/16 • Number of events 5 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
28.9%
13/45 • Number of events 23 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
33.3%
15/45 • Number of events 40 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
13.3%
2/15 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Administration site warmth
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Chills
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
100.0%
4/4 • Number of events 5 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
62.5%
10/16 • Number of events 18 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
75.0%
12/16 • Number of events 24 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
30.0%
3/10 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
68.9%
31/45 • Number of events 59 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
66.7%
30/45 • Number of events 62 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
40.0%
6/15 • Number of events 10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Feeling hot
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
18.8%
3/16 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Injection site hyperaesthesia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Injection site induration
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Injection site pruritus
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
18.8%
3/16 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Injection site rash
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Injection site warmth
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Malaise
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
50.0%
2/4 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
18.8%
3/16 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
28.9%
13/45 • Number of events 17 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
33.3%
15/45 • Number of events 20 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Thirst
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
3/45 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
8.9%
4/45 • Number of events 5 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
25.0%
4/16 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
20.0%
2/10 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
18.8%
3/16 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
20.0%
2/10 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
17.8%
8/45 • Number of events 9 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
17.8%
8/45 • Number of events 8 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
20.0%
3/15 • Number of events 5 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
18.8%
3/16 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
20.0%
2/10 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Investigations
Platelet count increased
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
3/45 • Number of events 5 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
50.0%
2/4 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
18.8%
3/16 • Number of events 5 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
25.0%
4/16 • Number of events 7 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
46.7%
21/45 • Number of events 36 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
44.4%
20/45 • Number of events 37 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
53.3%
8/15 • Number of events 11 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
50.0%
2/4 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
12.5%
2/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
4/4 • Number of events 7 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
75.0%
3/4 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
56.2%
9/16 • Number of events 15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
68.8%
11/16 • Number of events 20 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
64.4%
29/45 • Number of events 58 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
68.9%
31/45 • Number of events 60 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
40.0%
6/15 • Number of events 12 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Nervous system disorders
Headache
|
75.0%
3/4 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
75.0%
3/4 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
50.0%
8/16 • Number of events 15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
68.8%
11/16 • Number of events 19 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
40.0%
4/10 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
84.4%
38/45 • Number of events 70 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
77.8%
35/45 • Number of events 77 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
53.3%
8/15 • Number of events 12 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
3/45 • Number of events 5 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
10.0%
1/10 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Asthenia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Hypothermia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
11.1%
5/45 • Number of events 6 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
General disorders
Vaccination site urticaria
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Body tinea
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
3/45 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
13.3%
2/15 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
3/45 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Investigations
Heart rate decreased
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
3/45 • Number of events 4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
13.3%
6/45 • Number of events 7 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
15.6%
7/45 • Number of events 7 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 3 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Renal and urinary disorders
Urethral discharge
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.2%
1/16 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
3/45 • Number of events 6 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
6.7%
1/15 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
2.2%
1/45 • Number of events 1 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/4 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/16 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/10 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/45 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
4.4%
2/45 • Number of events 2 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
0.00%
0/15 • SAEs and All-cause mortality were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7, Day 57 to Day 63 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28, Day 57 to Day 84 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline to 7 days post-vaccination (Day 8, Day 64 and Day 176 respectively) and 28 days post-vaccination (Day 29, Day 85 and Day 197 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
|
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