Trial Outcomes & Findings for Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants (NCT NCT03343626)
NCT ID: NCT03343626
Last Updated: 2022-02-11
Results Overview
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after first vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), erythema (\<25 mm, mild: \>=25 to- \<=50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm), and swelling and induration (\<25 mm, mild: \>=25 to \<=-50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm). Only categories for which there was at least 1 participant are reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
271 participants
Primary outcome timeframe
Within 7 days after Dose 1 (Day 8)
Results posted on
2022-02-11
Participant Flow
Study participants, aged \>=18 to \<=49 years, were enrolled in this Phase 1 study in 9 sites in the United States and Puerto Rico from 13 November 2017 to 24 November 2020.
Flavivirus (FV) status was determined using a Luminex assay targeting 13 FV. FV-naïve participants with median fluorescent intensity (MFI) below that assigned for negative cut-off were first enrolled in FV-naïve Cohort in ratio 1:1:1:1 to receive either placebo or purified inactivated Zika virus vaccine (PIZV). After positive recommendation from data monitoring committee, FV-primed participants, with MFI\>500 were enrolled in FV-primed Cohort in ratio 1:1:1:1 to receive either placebo or PIZV.
Participant milestones
| Measure |
Flavivirus-naïve Cohort: Placebo
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
31
|
32
|
36
|
37
|
37
|
36
|
|
Overall Study
Safety Analysis Set
|
31
|
31
|
31
|
32
|
36
|
37
|
37
|
36
|
|
Overall Study
Full Analysis Set
|
30
|
28
|
31
|
30
|
34
|
34
|
34
|
34
|
|
Overall Study
Per Protocol Set
|
28
|
25
|
29
|
30
|
34
|
33
|
34
|
33
|
|
Overall Study
COMPLETED
|
25
|
26
|
29
|
24
|
29
|
32
|
32
|
25
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
2
|
8
|
7
|
5
|
5
|
11
|
Reasons for withdrawal
| Measure |
Flavivirus-naïve Cohort: Placebo
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
2
|
5
|
4
|
4
|
4
|
7
|
|
Overall Study
Withdrawal of Consent
|
2
|
1
|
0
|
3
|
3
|
1
|
1
|
2
|
|
Overall Study
Reason not Specified
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Data Entry Error
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants
Baseline characteristics by cohort
| Measure |
Flavivirus-naïve Cohort: Placebo
n=31 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=31 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=32 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=37 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=37 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=36 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 8.93 • n=5 Participants
|
34.9 years
STANDARD_DEVIATION 9.52 • n=7 Participants
|
35.8 years
STANDARD_DEVIATION 8.86 • n=5 Participants
|
34.1 years
STANDARD_DEVIATION 8.50 • n=4 Participants
|
34.7 years
STANDARD_DEVIATION 8.20 • n=21 Participants
|
35.5 years
STANDARD_DEVIATION 8.71 • n=8 Participants
|
37.0 years
STANDARD_DEVIATION 8.89 • n=8 Participants
|
35.4 years
STANDARD_DEVIATION 8.45 • n=24 Participants
|
35.5 years
STANDARD_DEVIATION 8.69 • n=42 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
158 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
113 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
151 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
119 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
215 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States of America
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
21 Participants
n=24 Participants
|
209 Participants
n=42 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
62 Participants
n=42 Participants
|
|
Body Mass Index (BMI)
|
27.921 kg/m^2
STANDARD_DEVIATION 4.2049 • n=5 Participants
|
27.527 kg/m^2
STANDARD_DEVIATION 4.7632 • n=7 Participants
|
27.541 kg/m^2
STANDARD_DEVIATION 3.7165 • n=5 Participants
|
26.750 kg/m^2
STANDARD_DEVIATION 3.6511 • n=4 Participants
|
27.398 kg/m^2
STANDARD_DEVIATION 3.5244 • n=21 Participants
|
27.054 kg/m^2
STANDARD_DEVIATION 4.7105 • n=8 Participants
|
26.982 kg/m^2
STANDARD_DEVIATION 4.1240 • n=8 Participants
|
28.072 kg/m^2
STANDARD_DEVIATION 4.4735 • n=24 Participants
|
27.398 kg/m^2
STANDARD_DEVIATION 4.1433 • n=42 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1 (Day 8)Population: Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. Overall number of participants are the number of participants with data available for analyses.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after first vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), erythema (\<25 mm, mild: \>=25 to- \<=50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm), and swelling and induration (\<25 mm, mild: \>=25 to \<=-50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm). Only categories for which there was at least 1 participant are reported.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=30 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=30 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=31 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=33 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=36 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=35 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Pain, Mild
|
13.3 percentage of participants
|
30.0 percentage of participants
|
32.3 percentage of participants
|
38.7 percentage of participants
|
8.3 percentage of participants
|
33.3 percentage of participants
|
30.6 percentage of participants
|
34.3 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Pain, Moderate
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
9.1 percentage of participants
|
8.3 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Pain, Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Erythema, <25 mm
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.2 percentage of participants
|
5.6 percentage of participants
|
3.0 percentage of participants
|
2.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Induration, <25 mm
|
0.0 percentage of participants
|
0.0 percentage of participants
|
9.7 percentage of participants
|
6.5 percentage of participants
|
0.0 percentage of participants
|
3.0 percentage of participants
|
5.6 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Swelling, <25 mm
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
6.1 percentage of participants
|
5.6 percentage of participants
|
2.9 percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 2 (Day 36)Population: Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. Overall number of participants are the number of participants with data available for analyses.
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after first vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), erythema (\<25 mm, mild: \>=25 to \<=50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm), and swelling and induration (\<25 mm, mild: \>=25 to \<=50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm). Only categories for which there was at least 1 participant are reported.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=28 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=27 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=30 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=30 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=33 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=32 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=32 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=34 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Pain, Mild
|
14.3 percentage of participants
|
29.6 percentage of participants
|
30.0 percentage of participants
|
36.7 percentage of participants
|
18.2 percentage of participants
|
21.9 percentage of participants
|
21.9 percentage of participants
|
20.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Pain, Moderate
|
0.0 percentage of participants
|
0.0 percentage of participants
|
6.7 percentage of participants
|
3.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
6.3 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Erythema, <25 mm
|
3.6 percentage of participants
|
0.0 percentage of participants
|
3.3 percentage of participants
|
3.3 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
3.1 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Erythema, Mild
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Induration, <25 mm
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Swelling, <25 mm
|
0.0 percentage of participants
|
0.0 percentage of participants
|
6.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Reactions by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Swelling, Mild
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1 (Day 8)Population: Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. Number analyzed is the number of participants with data available for analyses in the specific category.
Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs (headache, fatigue, malaise, arthralgia, and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was graded from 1 to 4 by severity; where 1=Mild: 38.0-38.4°C, 2=Moderate: 38.5-38.9°C, 3=Severe: 39.0-40°C, and 4=Potentially life threatening:\>40°C. Only categories for which there was at least 1 participant are reported.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=31 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=31 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=32 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=37 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=37 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=36 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Fever, Mild
|
3.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Fever, Moderate
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Headache, Mild
|
20.0 percentage of participants
|
13.3 percentage of participants
|
19.4 percentage of participants
|
12.9 percentage of participants
|
11.1 percentage of participants
|
12.1 percentage of participants
|
13.9 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Headache, Moderate
|
13.3 percentage of participants
|
3.3 percentage of participants
|
6.5 percentage of participants
|
0.0 percentage of participants
|
2.8 percentage of participants
|
3.0 percentage of participants
|
5.6 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Headache, Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.8 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Fatigue, Mild
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.1 percentage of participants
|
25.8 percentage of participants
|
16.7 percentage of participants
|
6.1 percentage of participants
|
25.0 percentage of participants
|
17.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Fatigue, Moderate
|
6.7 percentage of participants
|
6.7 percentage of participants
|
3.2 percentage of participants
|
6.5 percentage of participants
|
8.3 percentage of participants
|
3.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Arthralgia, Mild
|
3.3 percentage of participants
|
0.0 percentage of participants
|
3.2 percentage of participants
|
6.5 percentage of participants
|
8.3 percentage of participants
|
12.1 percentage of participants
|
11.1 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Arthralgia, Moderate
|
0.0 percentage of participants
|
3.3 percentage of participants
|
0.0 percentage of participants
|
3.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Myalgia, Mild
|
6.7 percentage of participants
|
6.7 percentage of participants
|
16.1 percentage of participants
|
12.9 percentage of participants
|
19.4 percentage of participants
|
12.1 percentage of participants
|
13.9 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Myalgia, Moderate
|
3.3 percentage of participants
|
3.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Myalgia, Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.0 percentage of participants
|
0.0 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Malaise, Mild
|
6.7 percentage of participants
|
3.3 percentage of participants
|
3.2 percentage of participants
|
12.9 percentage of participants
|
19.4 percentage of participants
|
12.1 percentage of participants
|
16.7 percentage of participants
|
22.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity Within 7 Days After Dose 1 of PIZV or Placebo
Malaise, Moderate
|
6.7 percentage of participants
|
3.3 percentage of participants
|
3.2 percentage of participants
|
0.0 percentage of participants
|
2.8 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 2 (Day 36)Population: Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo. Number analyzed is the number of participants with data available for analyses in the specific category.
Solicited systemic AEs included fever, headache, fatigue, malaise, arthralgia, and myalgia that occurred within 7 days of first vaccination. Solicited systemic AEs (headache, fatigue, malaise, arthralgia, and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was graded from 1 to 4 by severity; where 1=Mild: 38.0-38.4°C, 2=Moderate: 38.5-38.9°C, 3=Severe: 39.0-40°C, and 4=Potentially life threatening:\>40°C. Only categories for which there was at least 1 participant are reported.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=31 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=31 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=32 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=37 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=37 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=36 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Fever, Mild
|
3.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Fever, Severe
|
3.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
6.4 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Headache, Mild
|
6.9 percentage of participants
|
14.8 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
6.1 percentage of participants
|
6.3 percentage of participants
|
12.5 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Headache, Moderate
|
3.4 percentage of participants
|
0.0 percentage of participants
|
3.3 percentage of participants
|
3.3 percentage of participants
|
3.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Headache, Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Fatigue, Mild
|
13.8 percentage of participants
|
11.1 percentage of participants
|
3.3 percentage of participants
|
13.3 percentage of participants
|
9.1 percentage of participants
|
3.1 percentage of participants
|
9.4 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Fatigue, Moderate
|
6.9 percentage of participants
|
0.0 percentage of participants
|
3.3 percentage of participants
|
3.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Arthralgia, Mild
|
0.0 percentage of participants
|
7.4 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
9.4 percentage of participants
|
3.1 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Arthralgia, Moderate
|
3.4 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Arthralgia, Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Myalgia, Mild
|
0.0 percentage of participants
|
7.4 percentage of participants
|
3.3 percentage of participants
|
3.3 percentage of participants
|
9.1 percentage of participants
|
12.5 percentage of participants
|
6.3 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Myalgia, Moderate
|
6.9 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Myalgia, Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Malaise, Mild
|
3.4 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
6.7 percentage of participants
|
12.1 percentage of participants
|
3.1 percentage of participants
|
6.3 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Malaise, Moderate
|
3.4 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.3 percentage of participants
|
3.0 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs by Severity Within 7 Days After Dose 2 of PIZV or Placebo
Malaise, Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
3.1 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 1 (Day 29)Population: Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo.
An AE was defined as any untoward medical occurrence in participants administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=31 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=31 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=32 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=37 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=37 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=36 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Non-serious Unsolicited AE Within 28 Days After Dose 1 of PIZV or Placebo
|
29.0 percentage of participants
|
19.4 percentage of participants
|
29.0 percentage of participants
|
9.4 percentage of participants
|
22.2 percentage of participants
|
21.6 percentage of participants
|
21.6 percentage of participants
|
16.7 percentage of participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 2 (Day 57)Population: Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo.
An AE was defined as any untoward medical occurrence in a clinical investigation participants administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=31 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=31 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=32 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=37 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=37 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=36 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Non-serious Unsolicited AE Within 28 Days After Dose 2 of PIZV or Placebo
|
16.1 percentage of participants
|
16.1 percentage of participants
|
9.7 percentage of participants
|
12.5 percentage of participants
|
8.3 percentage of participants
|
13.5 percentage of participants
|
13.5 percentage of participants
|
13.9 percentage of participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 1 (Day 29)Population: Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo.
A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=31 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=31 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=32 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=37 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=37 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=36 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Serious Adverse Event (SAE) Within 28 Days After Dose 1 of PIZV or Placebo
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
2.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Within 28 days after Dose 2 (Day 57)Population: Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo.
A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=31 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=31 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=32 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=37 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=37 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=36 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One SAE Within 28 Days After Dose 2 of PIZV or Placebo
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: 28 days after Dose 2 (Day 57)Population: Per-Protocol Set (PPS) included participants in the Full Analysis Set (FAS) who have no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Overall number of participants analyzed are the number of participants with data available for analyses.
GMTs of neutralizing antibodies for ZIKV were measured by the Zika plaque reduction neutralization test (PRNT) test, by assessing the quantity of neutralizing antibodies that bind ZIKV in the assay. The assay results were reported as titers (reciprocal value of the dilution of the serum from the vaccinated individual that inhibits for 50% the plaque formation).
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=27 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=23 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=28 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=28 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=31 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=30 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=31 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=30 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibody for Zika Virus (ZIKV) 28 Days After Dose 2 of PIZV or Placebo
|
5.00 titer
The upper and lower limit of 95% confidence interval were not available as the titers were below the limits of quantification. As prespecified in the study, the antibody titers below the specific Limit of detection (LOD)=10 was assigned median titer value equal to half of the LOD titer.
|
1129.69 titer
Interval 749.38 to 1703.1
|
1992.33 titer
Interval 1401.28 to 2832.7
|
3689.89 titer
Interval 2676.75 to 5086.49
|
198.82 titer
Interval 91.73 to 430.97
|
597.63 titer
Interval 340.48 to 1049.0
|
1276.92 titer
Interval 806.0 to 2022.97
|
2590.54 titer
Interval 1649.18 to 4069.22
|
SECONDARY outcome
Timeframe: From day of first vaccination (Day 1) up to end of the study (Day 757)Population: Safety Analysis Set included all randomized participants who received at least one (1) dose of PIZV or placebo.
A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=31 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=31 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=32 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=37 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=37 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=36 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One SAE During the Study
|
3.2 percentage of participants
|
3.2 percentage of participants
|
0.0 percentage of participants
|
6.3 percentage of participants
|
2.8 percentage of participants
|
5.4 percentage of participants
|
0.0 percentage of participants
|
11.1 percentage of participants
|
SECONDARY outcome
Timeframe: 28 days after Dose 1 (Day 29); 6 months after Dose 2 (Day 211)Population: PPS included participants in the FAS who have no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Number analyzed is the number of participants with data available for analysis at the given tlmepoint.
GMTs of neutralizing antibodies for ZIKV were measured by Zika PRNT test, by assessing the quantity of neutralizing antibodies that bind ZIKV in the assay. The assay results were reported as titers (reciprocal value of the dilution of the serum from the vaccinated individual that inhibits for 50% the plaque formation).
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=28 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=25 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=29 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=30 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=34 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=33 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=34 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=33 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
GMTs of Neutralizing Antibody for ZIKV 28 Days After Dose 1 and 6 Months After Dose 2
Day 211
|
5.00 titer
The upper and lower limit of 95% confidence interval were not available as the titers were below the limits of quantification. As prespecified in the study, the antibody titers below the specific Limit of detection (LOD)=10 was assigned median titer value equal to half of the LOD titer.
|
151.24 titer
Interval 87.27 to 262.1
|
364.10 titer
Interval 237.97 to 557.08
|
613.28 titer
Interval 382.29 to 983.83
|
125.80 titer
Interval 48.02 to 329.55
|
258.44 titer
Interval 93.32 to 715.73
|
506.97 titer
Interval 228.56 to 1124.5
|
866.26 titer
Interval 445.59 to 1684.08
|
|
GMTs of Neutralizing Antibody for ZIKV 28 Days After Dose 1 and 6 Months After Dose 2
Day 29
|
5.00 titer
The upper and lower limit of 95% confidence interval were not available as the titers were below the limits of quantification. As prespecified in the study, the antibody titers below the specific Limit of detection (LOD)=10 was assigned median titer value equal to half of the LOD titer.
|
41.28 titer
Interval 18.74 to 90.95
|
93.76 titer
Interval 44.34 to 198.3
|
291.41 titer
Interval 161.74 to 525.06
|
164.06 titer
Interval 77.37 to 347.88
|
513.62 titer
Interval 259.9 to 1015.03
|
1002.69 titer
Interval 566.72 to 1774.06
|
1572.58 titer
Interval 864.63 to 2860.2
|
SECONDARY outcome
Timeframe: 12 months after Dose 2 (Day 393); 24 months after Dose 2 (Day 757)Population: PPS included participants in the FAS who had no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Overall number of participants analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint.
GMTs of neutralizing antibodies for ZIKV were measured by Zika PRNT test, by assessing the quantity of neutralizing antibodies that bind ZIKV in the assay. The assay results were reported as titers (reciprocal value of the dilution of the serum from the vaccinated individual that inhibits for 50% the plaque formation). As prespecified in the protocol, only data for applicable groups (Placebo and PIZV 10 mcg who were followed beyond Day 211) were analyzed and reported at Days 393 and 757 for Flavivirus-naïve Cohort and Flavivirus-primed Cohort.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=28 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=30 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=34 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=31 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
GMTs of Neutralizing Antibody for ZIKV 12 Months and 24 Months After Dose 2 in Applicable Groups
Day 393
|
5.00 titer
The upper and lower limit of 95% confidence interval were not available as the titers were below the limits of quantification. As prespecified in the study, the antibody titers below the specific Limit of detection (LOD)=10 was assigned median titer value equal to half of the LOD titer.
|
413.71 titer
Interval 215.67 to 793.58
|
103.88 titer
Interval 39.85 to 270.78
|
505.10 titer
Interval 287.58 to 887.15
|
—
|
—
|
—
|
—
|
|
GMTs of Neutralizing Antibody for ZIKV 12 Months and 24 Months After Dose 2 in Applicable Groups
Day 757
|
18.48 titer
Interval 6.0 to 56.91
|
427.41 titer
Interval 171.06 to 1067.93
|
324.26 titer
Interval 131.54 to 799.36
|
149.68 titer
Interval 56.68 to 395.24
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Dose 1 (Day 29); 28 days after Dose 2 (Day 57); 6 months after Dose 2 (Day 211)Population: PPS included participants in the FAS who had no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Number analyzed is the number of participants with data available for analysis at the given timepoint.
Seropositive participants were defined as participants with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=28 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=25 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=29 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=30 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=34 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=33 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=34 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=33 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Seropositive for Neutralizing Antibodies Against PIZV 28 Days After Dose 1, 28 Days After Dose 2, and 6 Months After Dose 2
Day 29
|
0.0 percentage of participants
Data for lower and upper limit of 95% CI was not estimable for this timepoint as the concentration were below the level of detection.
|
72.00 percentage of participants
Interval 50.61 to 87.93
|
82.14 percentage of participants
Interval 63.11 to 93.94
|
96.43 percentage of participants
Interval 81.65 to 99.91
|
85.29 percentage of participants
Interval 68.94 to 95.05
|
96.77 percentage of participants
Interval 83.3 to 99.92
|
100.00 percentage of participants
Interval 89.72 to 100.0
|
100.00 percentage of participants
Interval 89.42 to 100.0
|
|
Percentage of Participants Seropositive for Neutralizing Antibodies Against PIZV 28 Days After Dose 1, 28 Days After Dose 2, and 6 Months After Dose 2
Day 57
|
0.0 percentage of participants
Data for lower and upper limit of 95% CI was not estimable for this timepoint as the concentration were below the level of detection.
|
100.00 percentage of participants
Interval 85.18 to 100.0
|
100.00 percentage of participants
Interval 87.66 to 100.0
|
100.00 percentage of participants
Interval 87.66 to 100.0
|
87.10 percentage of participants
Interval 70.17 to 96.37
|
96.67 percentage of participants
Interval 82.78 to 99.92
|
100.00 percentage of participants
Interval 88.78 to 100.0
|
100.00 percentage of participants
Interval 88.43 to 100.0
|
|
Percentage of Participants Seropositive for Neutralizing Antibodies Against PIZV 28 Days After Dose 1, 28 Days After Dose 2, and 6 Months After Dose 2
Day 211
|
0.0 percentage of participants
Data for lower and upper limit of 95% CI was not estimable for this timepoint as the concentration were below the level of detection.
|
100.00 percentage of participants
Interval 83.16 to 100.0
|
100.00 percentage of participants
Interval 86.28 to 100.0
|
100.00 percentage of participants
Interval 85.18 to 100.0
|
76.67 percentage of participants
Interval 57.72 to 90.07
|
84.00 percentage of participants
Interval 63.92 to 95.46
|
100.00 percentage of participants
Interval 86.77 to 100.0
|
100.00 percentage of participants
Interval 86.77 to 100.0
|
SECONDARY outcome
Timeframe: 12 months after Dose 2 (Day 393); 24 months after Dose 2 (Day 757)Population: PPS included participants in the FAS who had no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Overall number of participants analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Seropositive participants were defined as participants with detectable serum antibodies (tested positive at or above limit of detection, LOD) as measured by the neutralization assay. As prespecified in the protocol, only data for applicable groups (Placebo and PIZV 10 mcg who were followed beyond Day 211) were analyzed and reported at Days 393 and 757 for Flavivirus-naïve Cohort and Flavivirus-primed Cohort.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=28 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=30 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=34 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=31 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Seropositive for PIZV 12 Months and 24 Months After Dose 2 in Applicable Groups
Day 393
|
0.00 percentage of participants
Interval 0.0 to 14.82
|
100.0 percentage of participants
Interval 83.89 to 100.0
|
65.63 percentage of participants
Interval 46.81 to 81.43
|
100.0 percentage of participants
Interval 86.28 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Seropositive for PIZV 12 Months and 24 Months After Dose 2 in Applicable Groups
Day 757
|
26.32 percentage of participants
Interval 9.15 to 51.2
|
93.75 percentage of participants
Interval 69.77 to 99.84
|
85.19 percentage of participants
Interval 66.27 to 95.81
|
76.19 percentage of participants
Interval 52.83 to 91.78
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Dose 1 (Day 29); 28 days after Dose 2 (Day 57)Population: Per-Protocol Set (PPS) included participants in the Full Analysis Set (FAS) who have no major protocol violations (relevant for the analysis, primary immunogenicity assessment or persistence assessment). Number analyzed is the number of participants with data available for analysis at the given tlmepoint.
Seroconverted participants were defined as participants at Baseline with detectable post-vaccination serum antibodies (test results are at or above LOD) and seropositive participants at Baseline with a four-fold increase in post-vaccination antibodies from Baseline, as measured by the neutralization assay.
Outcome measures
| Measure |
Flavivirus-naïve Cohort: Placebo
n=28 Participants
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=25 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=29 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=30 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=34 Participants
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=33 Participants
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=34 Participants
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=33 Participants
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Seroconverted for PIZV 28 Days Post Dose 1 and 28 Days Post Dose 2
Day 29
|
0.0 percentage of participants
Data for lower and upper limit of 95% CI was not estimable for this timepoint as the concentration were below the level of detection.
|
72.00 percentage of participants
Interval 50.61 to 87.93
|
82.14 percentage of participants
Interval 63.11 to 93.94
|
96.43 percentage of participants
Interval 81.65 to 99.91
|
2.94 percentage of participants
Interval 0.07 to 15.33
|
38.71 percentage of participants
Interval 21.85 to 57.81
|
50.00 percentage of participants
Interval 32.43 to 67.57
|
69.70 percentage of participants
Interval 51.29 to 84.41
|
|
Percentage of Participants Seroconverted for PIZV 28 Days Post Dose 1 and 28 Days Post Dose 2
Day 57
|
0.0 percentage of participants
Data for lower and upper limit of 95% CI was not estimable for this timepoint as the concentration were below the level of detection.
|
100.00 percentage of participants
Interval 85.18 to 100.0
|
100.00 percentage of participants
Interval 87.66 to 100.0
|
100.00 percentage of participants
Interval 87.66 to 100.0
|
6.45 percentage of participants
Interval 0.79 to 21.42
|
46.67 percentage of participants
Interval 28.34 to 65.67
|
54.84 percentage of participants
Interval 36.03 to 72.68
|
76.67 percentage of participants
Interval 57.72 to 90.07
|
Adverse Events
Flavivirus-naïve Cohort: Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Flavivirus-primed Cohort: Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flavivirus-naïve Cohort: Placebo
n=31 participants at risk
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=31 participants at risk
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 participants at risk
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=32 participants at risk
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 participants at risk
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=37 participants at risk
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=37 participants at risk
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=36 participants at risk
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
1/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
1/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Diverticulitis
|
3.2%
1/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Flavivirus-naïve Cohort: Placebo
n=31 participants at risk
Placebo injection, intramuscular (IM), once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 2 mcg (Low Dose)
n=31 participants at risk
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 5 mcg (Medium Dose)
n=31 participants at risk
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-naïve Cohort: PIZV 10 mcg (High Dose)
n=32 participants at risk
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: Placebo
n=36 participants at risk
Placebo injection, IM, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 2 mcg (Low Dose)
n=37 participants at risk
PIZV 0.5 mL, 2 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 5 mcg (Medium Dose)
n=37 participants at risk
PIZV 0.5 mL, 5 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
Flavivirus-primed Cohort: PIZV 10 mcg (High Dose)
n=36 participants at risk
PIZV 0.5 mL, 10 mcg antigen, IM injection, once on Day 1 (first dose) and Day 29 (second dose).
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
1/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
2/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.1%
3/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.4%
2/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
2/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
6.5%
2/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
2/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.1%
1/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.1%
3/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.1%
3/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
2/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.2%
1/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.2%
2/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.4%
2/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
1/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
1/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
3/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
2/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
1/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/31 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/32 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
1/37 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
2/36 • All Cause Mortality and Serious Adverse Events: From day of first vaccination (Day 1) up to end of the study (Day 757); Non Serious Adverse Events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 and Day 29
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER