Trial Outcomes & Findings for Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults (NCT NCT05613205)
NCT ID: NCT05613205
Last Updated: 2025-01-24
Results Overview
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 that lead to withholding of the study intervention administration were considered under this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
97 participants
Primary outcome timeframe
From Day 1 to Day 197
Results posted on
2025-01-24
Participant Flow
Out of 97 participants enrolled, 1 participant, who underwent post-screening procedures, withdrew from the study before randomisation and did not receive the study intervention. Therefore, 96 participants were randomised in the study.
Participant milestones
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
12
|
12
|
22
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults
Baseline characteristics by cohort
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=24 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.9 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
31.8 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
27.0 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
27.1 Years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
30.7 Years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
29.2 Years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
66 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
96 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7Population: The analysis was performed on the solicited safety set, which included all participants who received at least 1 dose of the study intervention and had solicited safety data during the specified timepoints.
Solicited administration site events included pain, redness, and swelling.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=23 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Administration-site Events After the First Vaccination
Swelling
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Administration-site Events After the First Vaccination
Pain
|
3 Participants
|
11 Participants
|
20 Participants
|
22 Participants
|
17 Participants
|
|
Number of Participants With Solicited Administration-site Events After the First Vaccination
Redness
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 169 to Day 175Population: The analysis was performed on the Solicited safety set. Only participants with data available at the mentioned timepoints were included in this analysis.
Solicited administration site events included pain, redness, and swelling.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=8 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=10 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=21 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=22 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=21 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Administration-site Events After the Second Vaccination
Pain
|
6 Participants
|
6 Participants
|
20 Participants
|
19 Participants
|
13 Participants
|
|
Number of Participants With Solicited Administration-site Events After the Second Vaccination
Redness
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Administration-site Events After the Second Vaccination
Swelling
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7Population: The analysis was performed on the Solicited safety set. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), fever, headache, and myalgia (muscle pain). Fever is defined as body temperature more than or equal to (\>=) 38.0 degrees Celsius (°C).
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=23 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Events After the First Vaccination
Arthralgia
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Events After the First Vaccination
Fatigue
|
4 Participants
|
3 Participants
|
9 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants With Solicited Systemic Events After the First Vaccination
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Events After the First Vaccination
Headache
|
5 Participants
|
5 Participants
|
10 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants With Solicited Systemic Events After the First Vaccination
Myalgia
|
3 Participants
|
3 Participants
|
7 Participants
|
15 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From Day 169 to Day 175Population: The analysis was performed on the Solicited safety set. Only participants with data available at the mentioned timepoints were included in this analysis.
The solicited systemic events included arthralgia (joint pain), fatigue (tiredness), fever, headache, and myalgia (muscle pain).
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=8 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=10 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=21 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=22 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=21 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Events After the Second Vaccination
Myalgia
|
3 Participants
|
3 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With Solicited Systemic Events After the Second Vaccination
Arthralgia
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Events After the Second Vaccination
Fatigue
|
1 Participants
|
3 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With Solicited Systemic Events After the Second Vaccination
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Events After the Second Vaccination
Headache
|
2 Participants
|
3 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 28Population: The analysis was performed on the unsolicited safety set, which included all participants who received at least 1 dose of the study intervention and reported having/not having unsolicited AEs during the specified timepoints.
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=24 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs) After the First Vaccination
|
7 Participants
|
9 Participants
|
15 Participants
|
12 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: From Day 169 to Day 196Population: The analysis was performed on the unsolicited safety set. Only participants with data available at the mentioned timepoints were included in this analysis.
An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=8 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=10 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=21 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=22 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=21 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events After the Second Vaccination
|
1 Participants
|
2 Participants
|
11 Participants
|
8 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 197Population: 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.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=24 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 197Population: 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.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=24 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With AEs/SAEs Leading to Withdrawal From the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 197Population: 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. SAEs that lead to withholding of the study intervention administration were considered under this outcome measure.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=24 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With SAEs Leading to Withholding Further Study Intervention Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 197Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in this analysis.
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 that lead to withholding of the study intervention administration were considered under this outcome measure.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=24 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With AEs Leading to Withholding Further Study Intervention Administration
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 8 compared to Day 1 (Baseline)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in the analysis.
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, hematocrit, lymphocytes, monocytes, neutrophils, platelets, leukocytes. Hepatic laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and renal laboratory parameters include creatinine and blood urea. Categories reported when comparing Day 1 (baseline) and Day 8 hematological, renal and hepatic laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Range level being classified as below, within or above the normal range.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=24 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine-Above-Within
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT-Below -Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT-Within-Within
|
11 Participants
|
11 Participants
|
23 Participants
|
23 Participants
|
24 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT-Within-Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
ALT-Above-Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST-Within-Within
|
12 Participants
|
12 Participants
|
23 Participants
|
22 Participants
|
23 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
AST-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine-Within-Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine-Within-Within
|
11 Participants
|
10 Participants
|
21 Participants
|
22 Participants
|
20 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine-Within-Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Creatinine-Above-Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood urea-Below-Below
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood urea-Within-Below
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood urea-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood urea-Below-Within
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood urea-Within-Within
|
11 Participants
|
10 Participants
|
20 Participants
|
20 Participants
|
24 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood urea-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood urea-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood urea-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Blood urea-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils-Within-Within
|
12 Participants
|
10 Participants
|
23 Participants
|
24 Participants
|
24 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils-Within-Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Basophils-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils-Within-Within
|
12 Participants
|
10 Participants
|
21 Participants
|
24 Participants
|
24 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Eosinophils-Above-Above
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hematocrit-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hematocrit-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hematocrit-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hematocrit-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hematocrit-Within-Within
|
12 Participants
|
12 Participants
|
22 Participants
|
22 Participants
|
23 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hematocrit-Above-Within
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hematocrit-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hematocrit-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hematocrit-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin-Within-Below
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin-Within-Within
|
12 Participants
|
12 Participants
|
21 Participants
|
23 Participants
|
22 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Hemoglobin-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes-Within-Within
|
10 Participants
|
11 Participants
|
22 Participants
|
24 Participants
|
24 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes-Above-Within
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes-Within-Above
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Lymphocytes-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes-Within-Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes-Within-Within
|
11 Participants
|
11 Participants
|
23 Participants
|
23 Participants
|
23 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Monocytes-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils-Below-Within
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils-Within-Within
|
12 Participants
|
10 Participants
|
20 Participants
|
22 Participants
|
24 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils-Above-Within
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils-Within-Above
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Neutrophils-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets-Within-Within
|
10 Participants
|
11 Participants
|
21 Participants
|
22 Participants
|
23 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets-Above-Within
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets-Within-Above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Platelets-Above-Above
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Erythrocytes-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Erythrocytes-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Erythrocytes-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Erythrocytes-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Erythrocytes-Within-Within
|
12 Participants
|
12 Participants
|
23 Participants
|
21 Participants
|
24 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Erythrocytes-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Erythrocytes-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Erythrocytes-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Erythrocytes-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Leukocytes-Below-Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Leukocytes-Within-Below
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Leukocytes-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Leukocytes-Below-Within
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Leukocytes-Within-Within
|
9 Participants
|
10 Participants
|
21 Participants
|
23 Participants
|
22 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Leukocytes-Above-Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Leukocytes-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Leukocytes-Within-Above
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 8
Leukocytes-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 176 compared to Day 169 (Baseline)Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in the analysis.
Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, hematocrit, lymphocytes, monocytes, neutrophils, platelets, leukocytes. Hepatic laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and renal laboratory parameters include creatinine and blood urea. Categories reported when comparing Day 169 (baseline) and Day 176 hematological, renal and hepatic laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Range level being classified as below, within or above the normal range.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=8 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=10 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=21 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=22 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=21 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST-Within-Within
|
7 Participants
|
10 Participants
|
19 Participants
|
20 Participants
|
20 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST-Above-Within
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST-Within-Above
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
AST-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine-Below-Below
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine-Within-Within
|
8 Participants
|
7 Participants
|
18 Participants
|
19 Participants
|
18 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine-Above-Within
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine-Within-Above
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Creatinine-Above-Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood urea-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood urea-Within-Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood urea-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood urea-Below-Within
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood urea-Within-Within
|
6 Participants
|
10 Participants
|
20 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood urea-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood urea-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood urea-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Blood urea-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils-Within-Within
|
8 Participants
|
10 Participants
|
21 Participants
|
22 Participants
|
21 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Basophils-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils-Within-Within
|
7 Participants
|
10 Participants
|
20 Participants
|
22 Participants
|
21 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils-Above-Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils-Within-Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Eosinophils-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hematocrit-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hematocrit-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hematocrit-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hematocrit-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hematocrit-Within-Within
|
8 Participants
|
10 Participants
|
18 Participants
|
22 Participants
|
20 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hematocrit-Above-Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hematocrit-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hematocrit-Within-Above
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hematocrit-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin-Within-Within
|
8 Participants
|
10 Participants
|
21 Participants
|
21 Participants
|
20 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Hemoglobin-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes-Within-Within
|
8 Participants
|
10 Participants
|
20 Participants
|
22 Participants
|
21 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes-Within-Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Lymphocytes-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes-Within-Within
|
8 Participants
|
10 Participants
|
21 Participants
|
22 Participants
|
21 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Monocytes-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils-Within-Within
|
8 Participants
|
10 Participants
|
18 Participants
|
22 Participants
|
15 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils-Above-Within
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils-Within-Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Neutrophils-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets-Within-Within
|
8 Participants
|
10 Participants
|
19 Participants
|
21 Participants
|
20 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets-Above-Within
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Platelets-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Erythrocytes-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Erythrocytes-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Erythrocytes-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Erythrocytes-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Erythrocytes-Within-Within
|
8 Participants
|
10 Participants
|
21 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Erythrocytes-Above-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Erythrocytes-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Erythrocytes-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Erythrocytes-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Leukocytes-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Leukocytes-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Leukocytes-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Leukocytes-Below-Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Leukocytes-Within-Within
|
8 Participants
|
10 Participants
|
18 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Leukocytes-Above-Within
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Leukocytes-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Leukocytes-Within-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
Leukocytes-Above-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT-Below-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT-Within-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT-Above-Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT-Below-Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT-Within-Within
|
7 Participants
|
10 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT-Above-Within
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT-Below-Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deviations From Normal or Baseline Values of Haematological, Renal, and Hepatic Panel Test Results at Day 176
ALT-Within-Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 197 to Day 337Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in the 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.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=24 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 197 to Day 337Population: The analysis was performed on the exposed set. Only participants with data available at the mentioned timepoints were included in the 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.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=24 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With AEs/SAEs Leading to Withdrawal From the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 1 (pre-dose 1), Day 29, Day 169 (pre-Dose 2), Day 176 and Day 197Population: The analysis was performed on Per-protocol set, which included all eligible participants who received each dose 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 during the specified timepoints.
Anti-Vi specific IgG antibodies were measured by an anti-Vi IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit. Blood samples were collected at specified timepoints.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=11 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=21 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Anti-Vi Antigen Immunoglobulin G (IgG) Antibody Concentrations
Day 1 (pre-dose 1)
|
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)
|
1.52 microgram per milliliter (µg/mL)
Interval 0.93 to 2.48
|
1.14 microgram per milliliter (µg/mL)
Interval 1.06 to 1.23
|
1.17 microgram per milliliter (µg/mL)
Interval 1.03 to 1.33
|
1.10 microgram per milliliter (µg/mL)
95% CI are not applicable for GMCs at Day 1 when all participants were below LLOQ
|
|
Geometric Mean Concentrations (GMCs) of Anti-Vi Antigen Immunoglobulin G (IgG) Antibody Concentrations
Day 29
|
14.12 microgram per milliliter (µg/mL)
Interval 8.21 to 24.29
|
19.61 microgram per milliliter (µg/mL)
Interval 9.1 to 42.28
|
60.52 microgram per milliliter (µg/mL)
Interval 35.28 to 103.82
|
36.97 microgram per milliliter (µg/mL)
Interval 20.56 to 66.48
|
4.95 microgram per milliliter (µg/mL)
Interval 3.23 to 7.59
|
|
Geometric Mean Concentrations (GMCs) of Anti-Vi Antigen Immunoglobulin G (IgG) Antibody Concentrations
Day 169 (pre-Dose 2)
|
4.36 microgram per milliliter (µg/mL)
Interval 2.01 to 9.47
|
11.17 microgram per milliliter (µg/mL)
Interval 4.79 to 26.03
|
18.58 microgram per milliliter (µg/mL)
Interval 9.97 to 34.6
|
12.55 microgram per milliliter (µg/mL)
Interval 7.06 to 22.32
|
6.18 microgram per milliliter (µg/mL)
Interval 3.5 to 10.92
|
|
Geometric Mean Concentrations (GMCs) of Anti-Vi Antigen Immunoglobulin G (IgG) Antibody Concentrations
Day 176
|
10.90 microgram per milliliter (µg/mL)
Interval 4.72 to 25.21
|
18.78 microgram per milliliter (µg/mL)
Interval 9.05 to 38.97
|
32.38 microgram per milliliter (µg/mL)
Interval 19.82 to 52.89
|
56.78 microgram per milliliter (µg/mL)
Interval 38.23 to 84.32
|
5.15 microgram per milliliter (µg/mL)
Interval 3.02 to 8.77
|
|
Geometric Mean Concentrations (GMCs) of Anti-Vi Antigen Immunoglobulin G (IgG) Antibody Concentrations
Day 197
|
10.16 microgram per milliliter (µg/mL)
Interval 5.08 to 20.3
|
18.88 microgram per milliliter (µg/mL)
Interval 8.23 to 43.29
|
33.75 microgram per milliliter (µg/mL)
Interval 17.78 to 64.07
|
37.14 microgram per milliliter (µg/mL)
Interval 23.79 to 58.0
|
5.17 microgram per milliliter (µg/mL)
Interval 3.14 to 8.52
|
SECONDARY outcome
Timeframe: At Day 29, Day 169, Day 176, and Day 197 compared to Day 1 (baseline)Population: The analysis was performed on the Per-protocol set. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-Vi specific IgG antibodies were measured by an anti-Vi IgG ELISA kit. Blood samples were collected at specified timepoints. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=11 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=21 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Geometric Mean Ratio (GMR) for Anti-Vi Antigen IgG Antibody Concentrations
Day 29
|
12.84 Ratio
Interval 7.46 to 22.08
|
12.90 Ratio
Interval 6.77 to 24.58
|
53.01 Ratio
Interval 31.94 to 87.99
|
31.55 Ratio
Interval 18.74 to 53.11
|
4.50 Ratio
Interval 2.93 to 6.9
|
|
Geometric Mean Ratio (GMR) for Anti-Vi Antigen IgG Antibody Concentrations
Day 169
|
3.96 Ratio
Interval 1.82 to 8.61
|
7.11 Ratio
Interval 3.51 to 14.4
|
16.27 Ratio
Interval 8.94 to 29.61
|
10.65 Ratio
Interval 6.59 to 17.22
|
5.62 Ratio
Interval 3.18 to 9.93
|
|
Geometric Mean Ratio (GMR) for Anti-Vi Antigen IgG Antibody Concentrations
Day 176
|
9.91 Ratio
Interval 4.29 to 22.92
|
11.96 Ratio
Interval 6.05 to 23.65
|
28.19 Ratio
Interval 17.72 to 44.84
|
47.45 Ratio
Interval 36.38 to 61.89
|
4.68 Ratio
Interval 2.75 to 7.97
|
|
Geometric Mean Ratio (GMR) for Anti-Vi Antigen IgG Antibody Concentrations
Day 197
|
9.23 Ratio
Interval 4.62 to 18.46
|
11.00 Ratio
Interval 5.15 to 23.49
|
29.22 Ratio
Interval 15.71 to 54.35
|
31.04 Ratio
Interval 23.14 to 41.65
|
4.70 Ratio
Interval 2.85 to 7.74
|
SECONDARY outcome
Timeframe: At Day 176 and Day 197 compared to Day 169 (baseline)Population: The analysis was performed on the Per-protocol set. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-Vi specific IgG antibodies were measured by an anti-Vi IgG ELISA kit. Blood samples were collected at specified timepoints. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=8 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=10 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=18 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=18 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=20 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
GMR for Anti-Vi Antigen IgG Antibody Concentrations
Day 176
|
2.50 Ratio
Interval 1.63 to 3.83
|
1.68 Ratio
Interval 1.16 to 2.43
|
2.00 Ratio
Interval 1.06 to 3.8
|
4.20 Ratio
Interval 2.46 to 7.17
|
0.82 Ratio
Interval 0.47 to 1.43
|
|
GMR for Anti-Vi Antigen IgG Antibody Concentrations
Day 197
|
2.33 Ratio
Interval 1.67 to 3.25
|
1.72 Ratio
Interval 1.17 to 2.54
|
1.71 Ratio
Interval 1.21 to 2.43
|
3.08 Ratio
Interval 2.09 to 4.53
|
0.77 Ratio
Interval 0.45 to 1.31
|
SECONDARY outcome
Timeframe: At Day 1 (pre-dose 1), Day 29, Day 169 (pre-dose 2), Day 176 and Day 197Population: The analysis was performed on the Per-protocol set. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-O:2 IgG antibodies in serum were measured by an ELISA assay. Blood samples were collected at specified timepoints.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=11 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=21 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
GMC of Anti-O:2 IgG Antibody Concentrations
Day 1 (pre-dose 1)
|
36.35 ELISA Units per milliliter (EU/mL)
Interval 15.21 to 86.89
|
28.31 ELISA Units per milliliter (EU/mL)
Interval 11.29 to 70.97
|
25.28 ELISA Units per milliliter (EU/mL)
Interval 14.73 to 43.39
|
25.90 ELISA Units per milliliter (EU/mL)
Interval 13.56 to 49.44
|
22.15 ELISA Units per milliliter (EU/mL)
Interval 13.18 to 37.23
|
|
GMC of Anti-O:2 IgG Antibody Concentrations
Day 29
|
4150.79 ELISA Units per milliliter (EU/mL)
Interval 1362.97 to 12640.82
|
559.62 ELISA Units per milliliter (EU/mL)
Interval 177.08 to 1768.5
|
4110.58 ELISA Units per milliliter (EU/mL)
Interval 1975.76 to 8552.1
|
668.30 ELISA Units per milliliter (EU/mL)
Interval 314.08 to 1422.01
|
28.19 ELISA Units per milliliter (EU/mL)
Interval 16.07 to 49.47
|
|
GMC of Anti-O:2 IgG Antibody Concentrations
Day 169 (pre-dose 2)
|
702.49 ELISA Units per milliliter (EU/mL)
Interval 138.39 to 3565.88
|
298.02 ELISA Units per milliliter (EU/mL)
Interval 85.01 to 1044.76
|
894.08 ELISA Units per milliliter (EU/mL)
Interval 397.22 to 2012.4
|
268.09 ELISA Units per milliliter (EU/mL)
Interval 124.74 to 576.18
|
18.43 ELISA Units per milliliter (EU/mL)
Interval 10.91 to 31.13
|
|
GMC of Anti-O:2 IgG Antibody Concentrations
Day 176
|
1079.75 ELISA Units per milliliter (EU/mL)
Interval 322.08 to 3619.77
|
464.70 ELISA Units per milliliter (EU/mL)
Interval 188.39 to 1146.25
|
1342.38 ELISA Units per milliliter (EU/mL)
Interval 644.96 to 2793.95
|
522.60 ELISA Units per milliliter (EU/mL)
Interval 264.74 to 1031.6
|
18.24 ELISA Units per milliliter (EU/mL)
Interval 10.38 to 32.05
|
|
GMC of Anti-O:2 IgG Antibody Concentrations
Day 197
|
958.21 ELISA Units per milliliter (EU/mL)
Interval 298.69 to 3074.02
|
520.77 ELISA Units per milliliter (EU/mL)
Interval 167.69 to 1617.23
|
956.89 ELISA Units per milliliter (EU/mL)
Interval 440.21 to 2080.03
|
388.50 ELISA Units per milliliter (EU/mL)
Interval 219.98 to 686.13
|
17.28 ELISA Units per milliliter (EU/mL)
Interval 10.13 to 29.47
|
SECONDARY outcome
Timeframe: At Day 29, Day 169, Day 176, and Day 197 compared to Day 1 (baseline)Population: The analysis was performed on the Per-protocol set. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-O:2 IgG antibodies in serum were measured by an ELISA assay. Blood samples were collected at specified timepoints. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=11 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=21 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
GMR for Anti-O:2 IgG Antibody Concentrations
Day 29
|
114.19 Ratio
Interval 44.83 to 290.86
|
19.77 Ratio
Interval 10.03 to 38.96
|
162.61 Ratio
Interval 91.17 to 290.04
|
25.81 Ratio
Interval 13.15 to 50.64
|
1.27 Ratio
Interval 1.02 to 1.6
|
|
GMR for Anti-O:2 IgG Antibody Concentrations
Day 169
|
26.15 Ratio
Interval 6.12 to 111.64
|
9.11 Ratio
Interval 3.83 to 21.64
|
37.28 Ratio
Interval 20.47 to 67.89
|
9.15 Ratio
Interval 4.52 to 18.51
|
0.92 Ratio
Interval 0.8 to 1.07
|
|
GMR for Anti-O:2 IgG Antibody Concentrations
Day 176
|
40.19 Ratio
Interval 11.79 to 136.94
|
14.20 Ratio
Interval 7.11 to 28.38
|
68.01 Ratio
Interval 39.46 to 117.23
|
19.12 Ratio
Interval 8.97 to 40.76
|
0.86 Ratio
Interval 0.77 to 0.96
|
|
GMR for Anti-O:2 IgG Antibody Concentrations
Day 197
|
35.66 Ratio
Interval 10.36 to 122.82
|
19.23 Ratio
Interval 9.58 to 38.6
|
51.16 Ratio
Interval 27.32 to 95.79
|
17.86 Ratio
Interval 9.42 to 33.86
|
0.95 Ratio
Interval 0.81 to 1.12
|
SECONDARY outcome
Timeframe: At Day 176 and Day 197 compared to Day 169 (baseline)Population: The analysis was performed on the Per-protocol set. Only participants with data available at the mentioned timepoints were included in this analysis.
Anti-O:2 IgG antibodies in serum were measured by an ELISA assay. Blood samples were collected at specified timepoint. Within participant GMRs were calculated as ratio of concentration in the post-vaccination timepoint to the pre-vaccination timepoint.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=8 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=10 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=18 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=18 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=20 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
GMR for Anti-O:2 IgG Antibody Concentrations
Day 176
|
1.54 Ratio
Interval 0.82 to 2.88
|
1.56 Ratio
Interval 1.07 to 2.28
|
1.76 Ratio
Interval 1.31 to 2.36
|
1.89 Ratio
Interval 1.34 to 2.67
|
0.98 Ratio
Interval 0.92 to 1.04
|
|
GMR for Anti-O:2 IgG Antibody Concentrations
Day 197
|
1.36 Ratio
Interval 0.67 to 2.76
|
1.70 Ratio
Interval 0.9 to 3.22
|
1.60 Ratio
Interval 1.23 to 2.09
|
2.01 Ratio
Interval 1.42 to 2.84
|
0.99 Ratio
Interval 0.92 to 1.07
|
SECONDARY outcome
Timeframe: At Day 1, Day 29, Day 169, Day 176 and Day 197Population: The analysis was performed on Full Analysis Set (FAS), which included all participants who received at least 1 dose of the study intervention and had post- vaccination immunogenicity data during the specified timepoints.
Blood samples were collected at specified timepoint for each component as measured by ELISA.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=11 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=22 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 1
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 29
|
12 Participants
|
10 Participants
|
22 Participants
|
23 Participants
|
13 Participants
|
|
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 169
|
6 Participants
|
10 Participants
|
20 Participants
|
18 Participants
|
13 Participants
|
|
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 176
|
6 Participants
|
9 Participants
|
19 Participants
|
21 Participants
|
12 Participants
|
|
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations Greater Than or Equal to (>=) 4.3 Micrograms Per Milliliter (µg/mL)
Day 197
|
7 Participants
|
9 Participants
|
20 Participants
|
22 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 29, Day 169, Day 176 and Day 197Population: The analysis was performed on FAS. 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 |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=11 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=22 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations >= 2.0 µg/mL
Day 176
|
8 Participants
|
10 Participants
|
19 Participants
|
21 Participants
|
16 Participants
|
|
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations >= 2.0 µg/mL
Day 1
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations >= 2.0 µg/mL
Day 29
|
12 Participants
|
11 Participants
|
22 Participants
|
23 Participants
|
20 Participants
|
|
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations >= 2.0 µg/mL
Day 169
|
6 Participants
|
10 Participants
|
20 Participants
|
22 Participants
|
17 Participants
|
|
Number of Participants With Anti-Vi Antigen IgG Antibody Concentrations >= 2.0 µg/mL
Day 197
|
8 Participants
|
10 Participants
|
21 Participants
|
22 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At Day 29, Day 169, Day 176 and Day 197 compared to Day 1 (baseline)Population: The analysis was performed on FAS. 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. 4-fold increase was defined as 4 times the baseline value of anti-O:2 IgG antibody concentrations.
Outcome measures
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 Participants
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=11 Participants
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=22 Participants
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 Participants
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 Participants
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least 4-fold Increase in Anti-O:2 IgG Antibody Concentrations
Day 29
|
12 Participants
|
9 Participants
|
22 Participants
|
20 Participants
|
1 Participants
|
|
Number of Participants With at Least 4-fold Increase in Anti-O:2 IgG Antibody Concentrations
Day 169
|
7 Participants
|
7 Participants
|
20 Participants
|
16 Participants
|
0 Participants
|
|
Number of Participants With at Least 4-fold Increase in Anti-O:2 IgG Antibody Concentrations
Day 176
|
8 Participants
|
8 Participants
|
20 Participants
|
18 Participants
|
0 Participants
|
|
Number of Participants With at Least 4-fold Increase in Anti-O:2 IgG Antibody Concentrations
Day 197
|
8 Participants
|
9 Participants
|
20 Participants
|
19 Participants
|
0 Participants
|
Adverse Events
Step 1a: Low Dose TYP04A Vaccine Without Alum
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Step 1b: Low Dose TYP03A Vaccine With Alum
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Step 2: Full Dose TYP04B Vaccine Without Alum
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Step 2: Full Dose TYP03B Vaccine With Alum
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Control: TYPHIM VI and BOOSTRIX Vaccine
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Step 1a: Low Dose TYP04A Vaccine Without Alum
n=12 participants at risk
Participants received a low dose of the TYP04A vaccine without Alum intramuscularly on Day 1 and Day 169.
|
Step 1b: Low Dose TYP03A Vaccine With Alum
n=12 participants at risk
Participants received low dose of the TYP03A vaccine with Alum intramuscularly on Day 1 and Day 169.
|
Step 2: Full Dose TYP04B Vaccine Without Alum
n=24 participants at risk
Participants received full dose of the TYP04B vaccine without Alum intramuscularly on Day 1 and day 169.
|
Step 2: Full Dose TYP03B Vaccine With Alum
n=24 participants at risk
Participants received full dose of the TYP03B vaccine with Alum intramuscularly on Day 1 and day 169.
|
Control: TYPHIM VI and BOOSTRIX Vaccine
n=24 participants at risk
Participants received TYPHIM VI as the comparator intramuscularly on Day 1 and BOOSTRIX as the comparator on Day 169.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Endocrine disorders
Thyroid calcification
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
2/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
2/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
2/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
2/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
2/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Administration site erythema
|
8.3%
1/12 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Administration site pain
|
50.0%
6/12 • Number of events 9 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
91.7%
11/12 • Number of events 17 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
87.5%
21/24 • Number of events 40 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
95.8%
23/24 • Number of events 41 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
91.7%
22/24 • Number of events 30 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Administration site pruritus
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Administration site swelling
|
8.3%
1/12 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
12.5%
3/24 • Number of events 3 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Axillary pain
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Chills
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Fatigue
|
33.3%
4/12 • Number of events 5 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
41.7%
5/12 • Number of events 6 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
45.8%
11/24 • Number of events 15 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
62.5%
15/24 • Number of events 22 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
62.5%
15/24 • Number of events 21 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Hangover
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
2/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Injection site haematoma
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Injection site movement impairment
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Injection site warmth
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Malaise
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Thirst
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
General disorders
Vaccination site movement impairment
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Body tinea
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Cystitis
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Infected dermal cyst
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
33.3%
4/12 • Number of events 4 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
12.5%
3/24 • Number of events 3 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
20.8%
5/24 • Number of events 5 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
20.8%
5/24 • Number of events 5 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
12.5%
3/24 • Number of events 4 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Extraskeletal ossification
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
2/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Investigations
Human papilloma virus test positive
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Investigations
White blood cell count increased
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
25.0%
3/12 • Number of events 4 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
16.7%
4/24 • Number of events 4 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
12.5%
3/24 • Number of events 5 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
16.7%
4/24 • Number of events 5 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
12.5%
3/24 • Number of events 3 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
2/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
4/12 • Number of events 6 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
33.3%
4/12 • Number of events 6 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
50.0%
12/24 • Number of events 16 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
66.7%
16/24 • Number of events 24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
54.2%
13/24 • Number of events 18 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
2/24 • Number of events 2 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Headache
|
50.0%
6/12 • Number of events 7 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
50.0%
6/12 • Number of events 9 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
58.3%
14/24 • Number of events 21 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
45.8%
11/24 • Number of events 15 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
70.8%
17/24 • Number of events 26 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Migraine
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Psychiatric disorders
Alcoholic hangover
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Renal and urinary disorders
Urethritis noninfective
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
1/12 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/12 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
4.2%
1/24 • Number of events 1 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
0.00%
0/24 • SAEs were reported from Day 1 to Day 337 (end of study), solicited AEs were reported from Day 1 to Day 7 and Day 169 to Day 175, and unsolicited AEs were reported from Day 1 to Day 28 and Day 169 to Day 196. Laboratory abnormalities were reported as change from baseline (Day 1[first dose] and Day 169 [second dose]) to 7 days post-vaccination (Day 8, and Day 176 respectively).
SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set. Exposed set included all participants who received at least 1 dose of the study intervention.
|
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