Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001) (NCT NCT01986010)
NCT ID: NCT01986010
Last Updated: 2021-11-01
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
190 participants
Primary outcome timeframe
Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)
Results posted on
2021-11-01
Participant Flow
Healthy males and females age 18 years of age and older were enrolled in this trial.
Participant milestones
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10 units (u) V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
14
|
10
|
11
|
19
|
10
|
4
|
12
|
10
|
10
|
11
|
10
|
11
|
16
|
11
|
4
|
|
Overall Study
Vaccination 1
|
13
|
14
|
14
|
10
|
11
|
19
|
10
|
4
|
12
|
10
|
10
|
11
|
10
|
11
|
16
|
11
|
4
|
|
Overall Study
Vaccination 2
|
12
|
13
|
12
|
10
|
9
|
19
|
10
|
4
|
11
|
10
|
10
|
10
|
10
|
9
|
16
|
10
|
4
|
|
Overall Study
Vaccination 3
|
10
|
10
|
9
|
10
|
9
|
15
|
10
|
4
|
10
|
10
|
10
|
8
|
10
|
9
|
13
|
10
|
4
|
|
Overall Study
COMPLETED
|
7
|
6
|
7
|
8
|
6
|
11
|
10
|
4
|
6
|
7
|
3
|
1
|
0
|
0
|
6
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
7
|
2
|
5
|
8
|
0
|
0
|
6
|
3
|
7
|
10
|
10
|
11
|
10
|
11
|
4
|
Reasons for withdrawal
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10 units (u) V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
2
|
2
|
2
|
0
|
0
|
4
|
2
|
0
|
1
|
1
|
1
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
0
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
2
|
0
|
0
|
|
Overall Study
Status Not Recorded
|
2
|
4
|
2
|
0
|
1
|
2
|
0
|
0
|
2
|
1
|
7
|
7
|
9
|
9
|
5
|
10
|
4
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)
Baseline characteristics by cohort
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=13 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=14 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=14 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=11 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=19 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=10 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=4 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=12 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=16 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
n=11 Participants
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
n=4 Participants
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.1 Years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
47.7 Years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
44.9 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
48.8 Years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
46.4 Years
STANDARD_DEVIATION 13.7 • n=21 Participants
|
46.5 Years
STANDARD_DEVIATION 15.1 • n=10 Participants
|
51.7 Years
STANDARD_DEVIATION 18.9 • n=115 Participants
|
47.5 Years
STANDARD_DEVIATION 16.7 • n=24 Participants
|
45.0 Years
STANDARD_DEVIATION 11.8 • n=42 Participants
|
32.5 Years
STANDARD_DEVIATION 10.9 • n=42 Participants
|
39.0 Years
STANDARD_DEVIATION 16.6 • n=42 Participants
|
41.1 Years
STANDARD_DEVIATION 14.5 • n=42 Participants
|
53.1 Years
STANDARD_DEVIATION 10.7 • n=36 Participants
|
40.0 Years
STANDARD_DEVIATION 14.4 • n=36 Participants
|
44.9 Years
STANDARD_DEVIATION 15.7 • n=24 Participants
|
36.1 Years
STANDARD_DEVIATION 12.7 • n=135 Participants
|
31.5 Years
STANDARD_DEVIATION 13.1 • n=136 Participants
|
44.1 Years
STANDARD_DEVIATION 14.6 • n=44 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
109 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
81 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
19 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
10 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
15 Participants
n=24 Participants
|
11 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
170 Participants
n=44 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
3 Participants
n=44 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
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
47 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
10 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
127 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
7 Participants
n=44 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=12 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=14 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=13 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=11 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=19 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=10 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=4 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=12 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=16 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
n=11 Participants
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
n=4 Participants
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Adverse Event (AE)
|
75.0 Percentage of participants
|
92.9 Percentage of participants
|
84.6 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
57.9 Percentage of participants
|
100.0 Percentage of participants
|
50.0 Percentage of participants
|
75.0 Percentage of participants
|
90.0 Percentage of participants
|
90.0 Percentage of participants
|
100.0 Percentage of participants
|
90.0 Percentage of participants
|
90.9 Percentage of participants
|
56.3 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
Injection-site AEs are defined as redness, swelling, and pain/tenderness.
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=12 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=14 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=13 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=11 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=19 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=10 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=4 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=12 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=16 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
n=11 Participants
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
n=4 Participants
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Injection-site AE
|
58.3 Percentage of participants
|
85.7 Percentage of participants
|
69.2 Percentage of participants
|
80.0 Percentage of participants
|
100.0 Percentage of participants
|
26.3 Percentage of participants
|
90.0 Percentage of participants
|
0.0 Percentage of participants
|
66.7 Percentage of participants
|
80.0 Percentage of participants
|
80.0 Percentage of participants
|
90.9 Percentage of participants
|
90.0 Percentage of participants
|
81.8 Percentage of participants
|
31.3 Percentage of participants
|
100.0 Percentage of participants
|
50.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
A Systemic AE includes, but is not exclusive of, the following AEs: fatigue, myalgia, headache and joint pain
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=12 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=14 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=13 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=11 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=19 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=10 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=4 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=12 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=16 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
n=11 Participants
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
n=4 Participants
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Systemic AE
|
66.7 Percentage of participants
|
64.3 Percentage of participants
|
69.2 Percentage of participants
|
90.0 Percentage of participants
|
90.9 Percentage of participants
|
57.9 Percentage of participants
|
80.0 Percentage of participants
|
50.0 Percentage of participants
|
66.7 Percentage of participants
|
90.0 Percentage of participants
|
70.0 Percentage of participants
|
100.0 Percentage of participants
|
70.0 Percentage of participants
|
90.9 Percentage of participants
|
56.3 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=12 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=14 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=13 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=11 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=19 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=10 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=4 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=12 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=16 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
n=11 Participants
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
n=4 Participants
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Serious Adverse Event (SAE)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks after vaccination on Day 1, Month 1 and Month 6 (up to Day 15, Week 6 and Week 26)Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
A serious adverse event is any adverse event occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. A serious vaccine-related adverse event was determined by the investigator to be related to the vaccine.
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=12 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=14 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=13 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=11 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=19 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=10 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=4 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=12 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=16 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
n=11 Participants
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
n=4 Participants
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Serious Vaccine-Related Adverse Event
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Month 6Population: All randomized participants who received at least 1 vaccination and had follow-up safety data available
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=12 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=14 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=13 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=11 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=19 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=10 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=4 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=12 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=16 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
n=11 Participants
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
n=4 Participants
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Treatment Due to an AE
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
9.1 Percentage of participants
|
0 Percentage of participants
|
9.1 Percentage of participants
|
0 Percentage of participants
|
9.1 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: All randomized participants who received at least 1 vaccination and had follow-up safety data available
An event of clinical interest (ECI) is identified as any overdose, elevated liver values meeting threshold criteria (aspartate aminotransferase or alanine aminotransferase ≥3x upper limit of normal (ULN); total bilirubin ≥2x ULN, and, at the same time, alkaline phosphatase \<2xULN). Additionally, confirmed, diagnosed autoimmune conditions are considered ECIs.
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=12 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=14 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=13 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=11 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=19 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=10 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=4 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=12 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=16 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
n=11 Participants
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
n=4 Participants
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Events of Clinical Interest (ECI)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Month 7 (1 month after vaccination 3 at Month 6)Population: All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid neutralizing antibody result.
Serum samples for measuring neutralizing antibodies using the Merck Neutralizing Antibody (NAb) assay were collected at month 7. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. The primary hypothesis was that for HCMV-seronegative participants, at least 1 of the vaccination groups receiving V160 formulated with or without adjuvant would exhibit higher HCMV-specific neutralizing antibody titers than the placebo group.
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=10 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=11 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=9 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=9 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=19 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=10 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=9 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=9 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=19 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccination 3
|
3301 Geometric Mean Titer
Interval 2097.0 to 5197.0
|
4177 Geometric Mean Titer
Interval 2721.0 to 6412.0
|
7740 Geometric Mean Titer
Interval 4190.0 to 14297.0
|
5701 Geometric Mean Titer
Interval 3526.0 to 9218.0
|
3535 Geometric Mean Titer
Interval 2115.0 to 5907.0
|
8601 Geometric Mean Titer
Interval 5305.0 to 13944.0
|
2224 Geometric Mean Titer
Interval 1522.0 to 3249.0
|
328 Geometric Mean Titer
Interval 210.0 to 511.0
|
1532 Geometric Mean Titer
Interval 1075.0 to 2182.0
|
1361 Geometric Mean Titer
Interval 886.0 to 2090.0
|
820 Geometric Mean Titer
Interval 524.0 to 1285.0
|
2573 Geometric Mean Titer
Interval 1863.0 to 3553.0
|
1241 Geometric Mean Titer
Interval 699.0 to 2203.0
|
1261 Geometric Mean Titer
Interval 733.0 to 2169.0
|
20 Geometric Mean Titer
Interval 20.0 to 20.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 7 (1 month after vaccination 3 at Month 6)Population: All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid PBMC interferon-gamma result.
In order to evaluate the cellular immune response to the vaccine(s), the HCMV enzyme-linked immunospot (ELISPOT) assay was used to detect interferon gamma (IFN-γ) secreting HCMV-specific cells from peripheral blood mononuclear cells (PBMCs). Results are expressed as the frequency of spot forming cells (SFCs) per million PBMCs (SFC/10\^6 PBMCs). Results are presented for the following HCMV proteins: pp65, Immediate early Protein 1 (IE1), Immediate early Protein 2 (IE2), Glycoprotein B (gB), and also for purified HCMV virion stock.
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=9 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=6 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=8 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=10 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=18 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=8 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=7 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=6 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=8 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=7 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=17 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
pp65
|
819 SFC/10^6 PBMCs
Interval 362.0 to 1853.0
|
419 SFC/10^6 PBMCs
Interval 174.0 to 1007.0
|
1384 SFC/10^6 PBMCs
Interval 66.0 to 2873.0
|
1105 SFC/10^6 PBMCs
Interval 422.0 to 2892.0
|
1206 SFC/10^6 PBMCs
Interval 565.0 to 2573.0
|
1080 SFC/10^6 PBMCs
Interval 570.0 to 2047.0
|
800 SFC/10^6 PBMCs
Interval 457.0 to 1401.0
|
886 SFC/10^6 PBMCs
Interval 394.0 to 1993.0
|
468 SFC/10^6 PBMCs
Interval 195.0 to 1125.0
|
865 SFC/10^6 PBMCs
Interval 429.0 to 1745.0
|
380 SFC/10^6 PBMCs
Interval 144.0 to 999.0
|
1325 SFC/10^6 PBMCs
Interval 656.0 to 2679.0
|
512 SFC/10^6 PBMCs
Interval 174.0 to 1502.0
|
1145 SFC/10^6 PBMCs
Interval 530.0 to 2474.0
|
19 SFC/10^6 PBMCs
Interval 11.0 to 34.0
|
—
|
—
|
|
Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
IE1
|
855 SFC/10^6 PBMCs
Interval 262.0 to 2786.0
|
340 SFC/10^6 PBMCs
Interval 85.0 to 1353.0
|
419 SFC/10^6 PBMCs
Interval 106.0 to 1660.0
|
370 SFC/10^6 PBMCs
Interval 79.0 to 1719.0
|
417 SFC/10^6 PBMCs
Interval 116.0 to 1507.0
|
379 SFC/10^6 PBMCs
Interval 111.0 to 1299.0
|
200 SFC/10^6 PBMCs
Interval 75.0 to 533.0
|
776 SFC/10^6 PBMCs
Interval 310.0 to 1943.0
|
358 SFC/10^6 PBMCs
Interval 123.0 to 1043.0
|
913 SFC/10^6 PBMCs
Interval 416.0 to 2003.0
|
577 SFC/10^6 PBMCs
Interval 158.0 to 2099.0
|
933 SFC/10^6 PBMCs
Interval 384.0 to 2264.0
|
742 SFC/10^6 PBMCs
Interval 326.0 to 1688.0
|
1796 SFC/10^6 PBMCs
Interval 702.0 to 4590.0
|
12 SFC/10^6 PBMCs
Interval 6.0 to 24.0
|
—
|
—
|
|
Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
IE2
|
122 SFC/10^6 PBMCs
Interval 48.0 to 312.0
|
101 SFC/10^6 PBMCs
Interval 47.0 to 216.0
|
309 SFC/10^6 PBMCs
Interval 151.0 to 631.0
|
72 SFC/10^6 PBMCs
Interval 34.0 to 156.0
|
93 SFC/10^6 PBMCs
Interval 32.0 to 271.0
|
32 SFC/10^6 PBMCs
Interval 18.0 to 55.0
|
49 SFC/10^6 PBMCs
Interval 32.0 to 74.0
|
119 SFC/10^6 PBMCs
Interval 45.0 to 313.0
|
22 SFC/10^6 PBMCs
Interval 8.0 to 62.0
|
34 SFC/10^6 PBMCs
Interval 15.0 to 80.0
|
146 SFC/10^6 PBMCs
Interval 35.0 to 609.0
|
86 SFC/10^6 PBMCs
Interval 32.0 to 228.0
|
131 SFC/10^6 PBMCs
Interval 52.0 to 330.0
|
194 SFC/10^6 PBMCs
Interval 66.0 to 576.0
|
10 SFC/10^6 PBMCs
Interval 4.0 to 22.0
|
—
|
—
|
|
Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
gB
|
195 SFC/10^6 PBMCs
Interval 69.0 to 555.0
|
287 SFC/10^6 PBMCs
Interval 74.0 to 1117.0
|
1137 SFC/10^6 PBMCs
Interval 422.0 to 3063.0
|
217 SFC/10^6 PBMCs
Interval 58.0 to 806.0
|
253 SFC/10^6 PBMCs
Interval 84.0 to 761.0
|
294 SFC/10^6 PBMCs
Interval 101.0 to 852.0
|
140 SFC/10^6 PBMCs
Interval 64.0 to 306.0
|
105 SFC/10^6 PBMCs
Interval 58.0 to 190.0
|
14 SFC/10^6 PBMCs
Interval 6.0 to 32.0
|
38 SFC/10^6 PBMCs
Interval 22.0 to 66.0
|
185 SFC/10^6 PBMCs
Interval 73.0 to 469.0
|
86 SFC/10^6 PBMCs
Interval 45.0 to 165.0
|
135 SFC/10^6 PBMCs
Interval 73.0 to 249.0
|
174 SFC/10^6 PBMCs
Interval 89.0 to 339.0
|
18 SFC/10^6 PBMCs
Interval 11.0 to 29.0
|
—
|
—
|
|
Geometric Mean Count of Peripheral Blood Mononuclear Cells Secreting Interferon-Gamma
Virus
|
1190 SFC/10^6 PBMCs
Interval 544.0 to 2605.0
|
384 SFC/10^6 PBMCs
Interval 114.0 to 1294.0
|
2134 SFC/10^6 PBMCs
Interval 995.0 to 4578.0
|
1348 SFC/10^6 PBMCs
Interval 481.0 to 3772.0
|
1708 SFC/10^6 PBMCs
Interval 732.0 to 3988.0
|
937 SFC/10^6 PBMCs
Interval 430.0 to 2044.0
|
1357 SFC/10^6 PBMCs
Interval 714.0 to 2579.0
|
668 SFC/10^6 PBMCs
Interval 334.0 to 1334.0
|
79 SFC/10^6 PBMCs
Interval 28.0 to 224.0
|
268 SFC/10^6 PBMCs
Interval 135.0 to 534.0
|
621 SFC/10^6 PBMCs
Interval 276.0 to 1400.0
|
777 SFC/10^6 PBMCs
Interval 420.0 to 1439.0
|
413 SFC/10^6 PBMCs
Interval 150.0 to 1139.0
|
1160 SFC/10^6 PBMCs
Interval 597.0 to 2253.0
|
17 SFC/10^6 PBMCs
Interval 10.0 to 27.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 7 (1 month after vaccination 3 at Month 6)Population: All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid whole blood interferon-gamma result.
In response to HCMV-specific stimulation of whole blood specimens the whole Blood Cytokine Stimulation (WBStim) assay was used to detect the secretion of interferon gamma (IFN -γ) by an ELISA assay. Results are presented for the following HCMV proteins: pp65, IE1, and gB.
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=10 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=7 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=6 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=7 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=6 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=9 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=15 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=8 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=8 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=9 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=9 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=6 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=7 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=7 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=13 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides
IE1
|
90 ug/mL
Interval 21.0 to 389.0
|
70 ug/mL
Interval 14.0 to 364.0
|
13 ug/mL
Interval 2.0 to 74.0
|
35 ug/mL
Interval 6.0 to 217.0
|
20 ug/mL
Interval 4.0 to 109.0
|
27 ug/mL
Interval 7.0 to 104.0
|
24 ug/mL
Interval 7.0 to 82.0
|
62 ug/mL
Interval 26.0 to 148.0
|
35 ug/mL
Interval 20.0 to 62.0
|
28 ug/mL
Interval 14.0 to 55.0
|
40 ug/mL
Interval 17.0 to 96.0
|
11 ug/mL
Interval 5.0 to 23.0
|
45 ug/mL
Interval 20.0 to 101.0
|
40 ug/mL
Interval 22.0 to 72.0
|
5 ug/mL
Interval 3.0 to 8.0
|
—
|
—
|
|
Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides
pp65
|
168 ug/mL
Interval 63.0 to 445.0
|
193 ug/mL
Interval 65.0 to 571.0
|
79 ug/mL
Interval 26.0 to 242.0
|
86 ug/mL
Interval 35.0 to 209.0
|
211 ug/mL
Interval 90.0 to 492.0
|
64 ug/mL
Interval 30.0 to 136.0
|
112 ug/mL
Interval 60.0 to 210.0
|
64 ug/mL
Interval 33.0 to 122.0
|
97 ug/mL
Interval 53.0 to 176.0
|
24 ug/mL
Interval 11.0 to 56.0
|
89 ug/mL
Interval 51.0 to 156.0
|
8 ug/mL
Interval 5.0 to 14.0
|
28 ug/mL
Interval 14.0 to 56.0
|
24 ug/mL
Interval 14.0 to 39.0
|
5 ug/mL
Interval 3.0 to 7.0
|
—
|
—
|
|
Geometric Mean Concentration of Interferon-Gamma After Stimulation of Whole Blood Sample With Pooled HCMV Antigen Peptides
gB
|
53 ug/mL
Interval 16.0 to 175.0
|
40 ug/mL
Interval 8.0 to 202.0
|
64 ug/mL
Interval 11.0 to 375.0
|
27 ug/mL
Interval 3.0 to 213.0
|
27 ug/mL
Interval 6.0 to 115.0
|
62 ug/mL
Interval 18.0 to 214.0
|
16 ug/mL
Interval 6.0 to 48.0
|
7 ug/mL
Interval 4.0 to 11.0
|
10 ug/mL
Interval 6.0 to 19.0
|
5 ug/mL
Interval 3.0 to 9.0
|
7 ug/mL
Interval 4.0 to 12.0
|
10 ug/mL
Interval 6.0 to 16.0
|
9 ug/mL
Interval 6.0 to 16.0
|
5 ug/mL
Interval 3.0 to 9.0
|
6 ug/mL
Interval 4.0 to 8.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 1 and 2 (one month after vaccination 1 [Day 1] and vaccination 2 [Month 1])Population: All randomized participants who received at least 1 dose of the study vaccine or placebo and had at least 1 valid neutralizing antibody result.
Serum samples for measuring neutralizing antibodies using the Merck NAb assay were collected at months 1 and 2. The LiCor-based near-infrared dye (NIRDye) In-Cell Western (ICW) HCMV microneutralization assay was used to detect and quantify anti-HCMV neutralizing antibodies. Values below the lower limit of titer are represented by NA.
Outcome measures
| Measure |
HCMV Seropositive (+) V160 10u Intramuscular (IM)
n=12 Participants
Participants seropositive for Human cytomegalovirus (HCMV) at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=14 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u IM
n=12 Participants
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 Participants
Participants seropositive for HCMV at Baseline received 100u V160 plus Merck Aluminum Phosphate Adjuvant (MAPA) adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 250u IM
n=9 Participants
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=10 Participants
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 30u ID
n=23 Participants
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by intradermal (ID) injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=11 Participants
Participants seropositive for HCMV at Baseline received vaccination with placebo by ID injection on Day 1, Month 1, and Month 6
|
HCMV Seronegative (-) V160 10u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received vaccination with 30u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=11 Participants
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=10 Participants
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=20 Participants
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
Participants seronegative for HCMV at Baseline received 30u V160 by ID injection on Day 1, Month 1, and Month 6
|
HCMV- Placebo ID
Participants seronegative for HCMV at Baseline received placebo by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2
Month 2
|
3144 Geometric Mean Titer
Interval 1893.0 to 5221.0
|
5443 Geometric Mean Titer
Interval 3472.0 to 8533.0
|
6959 Geometric Mean Titer
Interval 4088.0 to 11845.0
|
7022 Geometric Mean Titer
Interval 4126.0 to 11953.0
|
4261 Geometric Mean Titer
Interval 2432.0 to 7464.0
|
9412 Geometric Mean Titer
Interval 5529.0 to 16021.0
|
2313 Geometric Mean Titer
Interval 1468.0 to 3644.0
|
143 Geometric Mean Titer
Interval 89.0 to 230.0
|
264 Geometric Mean Titer
Interval 160.0 to 433.0
|
264 Geometric Mean Titer
Interval 161.0 to 433.0
|
288 Geometric Mean Titer
Interval 180.0 to 463.0
|
590 Geometric Mean Titer
Interval 359.0 to 968.0
|
589 Geometric Mean Titer
Interval 359.0 to 968.0
|
451 Geometric Mean Titer
Interval 275.0 to 741.0
|
NA Geometric Mean Titer
Values below the lower limit of titer are represented by NA.
|
—
|
—
|
|
Geometric Mean Titer of HCMV-specific Neutralizing Antibody After Vaccinations 1 and 2
Month 1
|
3124 Geometric Mean Titer
Interval 1887.0 to 5172.0
|
5186 Geometric Mean Titer
Interval 3252.0 to 8270.0
|
6232 Geometric Mean Titer
Interval 3764.0 to 10318.0
|
6695 Geometric Mean Titer
Interval 3854.0 to 11631.0
|
3831 Geometric Mean Titer
Interval 2140.0 to 6858.0
|
9127 Geometric Mean Titer
Interval 5253.0 to 15855.0
|
2335 Geometric Mean Titer
Interval 1485.0 to 3671.0
|
73 Geometric Mean Titer
Interval to 137.0
Values below the lower limit of titer are represented by NA.
|
95 Geometric Mean Titer
Interval 50.0 to 184.0
|
65 Geometric Mean Titer
Interval to 125.0
Values below the lower limit of titer are represented by NA.
|
91 Geometric Mean Titer
Interval 49.0 to 170.0
|
134 Geometric Mean Titer
Interval 70.0 to 258.0
|
281 Geometric Mean Titer
Interval 146.0 to 542.0
|
183 Geometric Mean Titer
Interval 95.0 to 351.0
|
NA Geometric Mean Titer
Values below the lower limit of titer are represented by NA.
|
—
|
—
|
Adverse Events
HCMV + V160 10u IM
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
HCMV + V160 30u IM
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
HCMV + V160 100u IM
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
HCMV+ V160 100u MAPA IM
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
HCMV + V160 250u IM
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
HCMV+ Placebo IM
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
HCMV + V160 30u ID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
HCMV+ Placebo ID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
HCMV- V160 10u IM
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
HCMV- V160 30u IM
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
HCMV- V160 30u MAPA IM
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
HCMV- V160 100u IM
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
HCMV- V160 100u MAPA IM
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
HCMV- V160 250u IM
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
HCMV- V160 Placebo IM
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
HCMV- V160 30u ID
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
HCMV- V160 Placebo ID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HCMV + V160 10u IM
n=13 participants at risk
Participants seropositive for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u IM
n=14 participants at risk
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 100u IM
n=14 participants at risk
Participants seropositive for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ V160 100u MAPA IM
n=10 participants at risk
Participants seropositive for HCMV at Baseline received 100u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 250u IM
n=11 participants at risk
Participants seropositive for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo IM
n=19 participants at risk
Participants seropositive for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV + V160 30u ID
n=10 participants at risk
Participants seropositive for HCMV at Baseline received 30u V160 vaccination by ID injection on Day 1, Month 1, and Month 6
|
HCMV+ Placebo ID
n=4 participants at risk
Participants seropositive for HCMV at Baseline received placebo vaccination by ID injection on Day 1, Month 1, and Month 6
|
HCMV- V160 10u IM
n=12 participants at risk
Participants seronegative for HCMV at Baseline received 10u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u IM
n=10 participants at risk
Participants seronegative for HCMV at Baseline received 30u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u MAPA IM
n=10 participants at risk
Participants seronegative for HCMV at Baseline received 30u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u IM
n=11 participants at risk
Participants seronegative for HCMV at Baseline received 100u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 100u MAPA IM
n=10 participants at risk
Participants seronegative for HCMV at Baseline received 100u V160 plus MAPA adjuvant vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 250u IM
n=11 participants at risk
Participants seronegative for HCMV at Baseline received 250u V160 vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo IM
n=16 participants at risk
Participants seronegative for HCMV at Baseline received placebo vaccination by IM injection on Day 1, Month 1, and Month 6
|
HCMV- V160 30u ID
n=11 participants at risk
Participants seronegative for HCMV at Baseline received 30u V160 vaccination by ID injection on Day 1, Month 1, and Month 6
|
HCMV- V160 Placebo ID
n=4 participants at risk
Participants seronegative for HCMV at Baseline received placebo vaccination by ID injection on Day 1, Month 1, and Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
20.0%
2/10 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
2/13 • Number of events 4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
28.6%
4/14 • Number of events 6 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
42.9%
6/14 • Number of events 8 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
50.0%
5/10 • Number of events 13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
54.5%
6/11 • Number of events 14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
26.3%
5/19 • Number of events 6 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
40.0%
4/10 • Number of events 10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
25.0%
1/4 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
41.7%
5/12 • Number of events 9 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
70.0%
7/10 • Number of events 12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
50.0%
5/10 • Number of events 10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
81.8%
9/11 • Number of events 18 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
50.0%
5/10 • Number of events 12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
72.7%
8/11 • Number of events 20 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
25.0%
4/16 • Number of events 5 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
36.4%
4/11 • Number of events 13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
25.0%
1/4 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
18.2%
2/11 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
25.0%
1/4 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Eye disorders
Eye pruritus
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
5.3%
1/19 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
18.2%
2/11 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
25.0%
1/4 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
5.3%
1/19 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
25.0%
1/4 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
5.3%
1/19 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
5.3%
1/19 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
5.3%
1/19 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
6.2%
1/16 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
16.7%
2/12 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
25.0%
1/4 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Asthenia
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Axillary pain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Chest pain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Chills
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
14.3%
2/14 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
18.2%
2/11 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
36.4%
4/11 • Number of events 6 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
27.3%
3/11 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Fatigue
|
46.2%
6/13 • Number of events 9 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
64.3%
9/14 • Number of events 13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
50.0%
7/14 • Number of events 19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
80.0%
8/10 • Number of events 22 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
72.7%
8/11 • Number of events 19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
47.4%
9/19 • Number of events 15 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
60.0%
6/10 • Number of events 22 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
25.0%
1/4 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
58.3%
7/12 • Number of events 15 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
50.0%
5/10 • Number of events 9 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
50.0%
5/10 • Number of events 13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
54.5%
6/11 • Number of events 20 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
60.0%
6/10 • Number of events 18 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
90.9%
10/11 • Number of events 37 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
50.0%
8/16 • Number of events 16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
72.7%
8/11 • Number of events 27 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
50.0%
2/4 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Influenza like illness
|
7.7%
1/13 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
20.0%
2/10 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site bruising
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
5.3%
1/19 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
18.2%
2/11 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site discolouration
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site discomfort
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site erythema
|
23.1%
3/13 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
21.4%
3/14 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
20.0%
2/10 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
18.2%
2/11 • Number of events 4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
15.8%
3/19 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
90.0%
9/10 • Number of events 26 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
16.7%
2/12 • Number of events 4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
30.0%
3/10 • Number of events 5 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
27.3%
3/11 • Number of events 4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
30.0%
3/10 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
27.3%
3/11 • Number of events 6 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
100.0%
11/11 • Number of events 32 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
50.0%
2/4 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site hypoaesthesia
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site induration
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site joint pain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site mass
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site movement impairment
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
14.3%
2/14 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site pain
|
46.2%
6/13 • Number of events 13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
85.7%
12/14 • Number of events 31 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
71.4%
10/14 • Number of events 18 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
70.0%
7/10 • Number of events 21 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
100.0%
11/11 • Number of events 35 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
26.3%
5/19 • Number of events 10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
70.0%
7/10 • Number of events 16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
66.7%
8/12 • Number of events 13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
80.0%
8/10 • Number of events 28 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
80.0%
8/10 • Number of events 19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
90.9%
10/11 • Number of events 24 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
80.0%
8/10 • Number of events 28 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
81.8%
9/11 • Number of events 35 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
31.2%
5/16 • Number of events 11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
81.8%
9/11 • Number of events 23 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site pruritus
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
70.0%
7/10 • Number of events 14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
81.8%
9/11 • Number of events 18 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site rash
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site reaction
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site scab
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site swelling
|
15.4%
2/13 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
14.3%
2/14 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
40.0%
4/10 • Number of events 5 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
27.3%
3/11 • Number of events 5 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
5.3%
1/19 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
90.0%
9/10 • Number of events 27 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
25.0%
3/12 • Number of events 5 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
20.0%
2/10 • Number of events 4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
27.3%
3/11 • Number of events 5 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
40.0%
4/10 • Number of events 9 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
27.3%
3/11 • Number of events 4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
6.2%
1/16 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
100.0%
11/11 • Number of events 34 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site ulcer
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site vesicles
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Injection site warmth
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Malaise
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
20.0%
2/10 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
18.2%
2/11 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Oedema peripheral
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Pain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
27.3%
3/11 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
45.5%
5/11 • Number of events 5 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
6.2%
1/16 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
5.3%
1/19 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Infections and infestations
Eye infection
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Infections and infestations
Gingivitis
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Infections and infestations
Infected bite
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
6.2%
1/16 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Infections and infestations
Injection site pustule
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
20.0%
2/10 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
27.3%
3/11 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
6.2%
1/16 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Bacterial test positive
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Blood glucose increased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Blood pressure increased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Blood urine present
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Body temperature increased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Eosinophil count decreased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
6.2%
1/16 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Eosinophil count increased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Monocyte count decreased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
14.3%
2/14 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Monocyte count increased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
Protein urine present
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
White blood cell count increased
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Investigations
White blood cells urine positive
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
3/13 • Number of events 4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
28.6%
4/14 • Number of events 4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
30.0%
3/10 • Number of events 11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
45.5%
5/11 • Number of events 6 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.5%
2/19 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
30.0%
3/10 • Number of events 10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
41.7%
5/12 • Number of events 7 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
20.0%
2/10 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
40.0%
4/10 • Number of events 8 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
45.5%
5/11 • Number of events 5 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
30.0%
3/10 • Number of events 7 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
54.5%
6/11 • Number of events 8 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
18.8%
3/16 • Number of events 4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
45.5%
5/11 • Number of events 14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
18.2%
2/11 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
8.3%
1/12 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Nervous system disorders
Headache
|
46.2%
6/13 • Number of events 11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
28.6%
4/14 • Number of events 4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
42.9%
6/14 • Number of events 14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
80.0%
8/10 • Number of events 20 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
54.5%
6/11 • Number of events 9 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
36.8%
7/19 • Number of events 13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
60.0%
6/10 • Number of events 21 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
41.7%
5/12 • Number of events 10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
70.0%
7/10 • Number of events 18 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
40.0%
4/10 • Number of events 13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
81.8%
9/11 • Number of events 17 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
40.0%
4/10 • Number of events 15 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
72.7%
8/11 • Number of events 20 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
31.2%
5/16 • Number of events 8 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
81.8%
9/11 • Number of events 27 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
50.0%
2/4 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
6.2%
1/16 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Nervous system disorders
Migraine
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Nervous system disorders
Tremor
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
6.2%
1/16 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
20.0%
2/10 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
6.2%
1/16 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
7.1%
1/14 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
18.2%
2/11 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
18.2%
2/11 • Number of events 2 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
12.5%
2/16 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
10.0%
1/10 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
5.3%
1/19 • Number of events 3 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Vascular disorders
Haematoma
|
7.7%
1/13 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
|
Vascular disorders
Hot flush
|
0.00%
0/13 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/14 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/19 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/12 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
9.1%
1/11 • Number of events 1 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/10 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/16 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/11 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
0.00%
0/4 • Up to 18 months
All randomized participants who received at least 1 vaccination
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER