Trial Outcomes & Findings for A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults (NCT NCT04453202)
NCT ID: NCT04453202
Last Updated: 2025-05-25
Results Overview
Geometric mean antibody titers (ELISA units per liter \[EU/L\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
459 participants
Primary outcome timeframe
14 days after vaccination on Day 1 (Day 15)
Results posted on
2025-05-25
Participant Flow
A total of 459 participants were enrolled, of which 454 were randomized and vaccinated in this study.
Participant milestones
| Measure |
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
51
|
48
|
25
|
49
|
49
|
26
|
27
|
51
|
26
|
|
Overall Study
Full Analysis Set (FAS)
|
51
|
51
|
51
|
48
|
25
|
49
|
49
|
26
|
27
|
51
|
26
|
|
Overall Study
Per-protocol Immunogenicity (PPI) Set
|
51
|
50
|
51
|
48
|
25
|
47
|
49
|
26
|
27
|
50
|
26
|
|
Overall Study
COMPLETED
|
50
|
48
|
50
|
45
|
24
|
47
|
48
|
26
|
27
|
48
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
3
|
1
|
2
|
1
|
0
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
2
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults
Baseline characteristics by cohort
| Measure |
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=48 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=25 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 2: Placebo
n=26 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=27 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 3: Placebo
n=26 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Total
n=454 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 6.97 • n=5 Participants
|
68.7 years
STANDARD_DEVIATION 7.08 • n=7 Participants
|
69.4 years
STANDARD_DEVIATION 6.56 • n=5 Participants
|
70.3 years
STANDARD_DEVIATION 6.82 • n=4 Participants
|
70 years
STANDARD_DEVIATION 6.44 • n=21 Participants
|
68.6 years
STANDARD_DEVIATION 6.69 • n=10 Participants
|
68.6 years
STANDARD_DEVIATION 5.68 • n=115 Participants
|
67.6 years
STANDARD_DEVIATION 5.34 • n=24 Participants
|
67.9 years
STANDARD_DEVIATION 4.51 • n=42 Participants
|
68.7 years
STANDARD_DEVIATION 5.41 • n=42 Participants
|
66.5 years
STANDARD_DEVIATION 5.09 • n=42 Participants
|
68.8 years
STANDARD_DEVIATION 6.25 • n=42 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
16 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
247 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
207 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
62 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
45 Participants
n=10 Participants
|
46 Participants
n=115 Participants
|
25 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
390 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 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
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
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
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
25 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
49 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
425 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 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
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=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
|
|
Region of Enrollment
UNITED STATES
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
49 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
51 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
454 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 14 days after vaccination on Day 1 (Day 15)Population: Per-protocol Immunogenicity (PPI) set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Geometric mean antibody titers (ELISA units per liter \[EU/L\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.
Outcome measures
| Measure |
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=44 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=46 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=45 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=45 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=24 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination
|
—
|
4907 EU/L
Interval 4030.0 to 5976.0
|
4681 EU/L
Interval 3696.0 to 5928.0
|
4038 EU/L
Interval 3042.0 to 5361.0
|
5238 EU/L
Interval 4070.0 to 6743.0
|
272 EU/L
Interval 212.0 to 350.0
|
PRIMARY outcome
Timeframe: Until 7 days after Vaccination on Day 1 (Day 8)Population: Full Analysis Set (FAS) included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Outcome measures
| Measure |
Cohort 3: Placebo
n=26 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=26 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=27 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=50 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
|
2 Participants
|
37 Participants
|
42 Participants
|
3 Participants
|
23 Participants
|
37 Participants
|
PRIMARY outcome
Timeframe: Until 7 days after Vaccination on Day 1 (Day 8)Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree celsius).
Outcome measures
| Measure |
Cohort 3: Placebo
n=26 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=26 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=27 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=50 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
|
7 Participants
|
39 Participants
|
43 Participants
|
8 Participants
|
19 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: Until 28 days after Vaccination on Day 1 (Day 29)Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
Outcome measures
| Measure |
Cohort 3: Placebo
n=26 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=26 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=27 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=51 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
|
2 Participants
|
13 Participants
|
8 Participants
|
7 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At 3 and 6 months after vaccination on Day 1Population: PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies participants who were evaluable at specified time points.
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 3 and 6 months after vaccination on Day 1 were reported.
Outcome measures
| Measure |
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=50 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=48 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=25 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1
3 months after vaccination on Day 1
|
—
|
2550 EU/L
Interval 2134.0 to 3047.0
|
2790 EU/L
Interval 2251.0 to 3459.0
|
1940 EU/L
Interval 1565.0 to 2405.0
|
2997 EU/L
Interval 2335.0 to 3846.0
|
315 EU/L
Interval 251.0 to 394.0
|
|
Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1
6 months after vaccination on Day 1
|
—
|
1568 EU/L
Interval 1351.0 to 1819.0
|
1424 EU/L
Interval 1126.0 to 1800.0
|
1247 EU/L
Interval 1053.0 to 1478.0
|
1834 EU/L
Interval 1478.0 to 2277.0
|
326 EU/L
Interval 256.0 to 414.0
|
SECONDARY outcome
Timeframe: At 14 days and 3 and 6 months after vaccination on Day 1Population: PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points.
RSV A2 strain neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% inhibitory concentration (IC50) units.
Outcome measures
| Measure |
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=50 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=48 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=25 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
14 days after vaccination on Day 1
|
—
|
6314 Titer
Interval 4800.0 to 8307.0
|
5140 Titer
Interval 3909.0 to 6758.0
|
4725 Titer
Interval 3407.0 to 6554.0
|
6194 Titer
Interval 4641.0 to 8265.0
|
294 Titer
Interval 239.0 to 363.0
|
|
Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
3 months after vaccination on Day 1
|
—
|
3760 Titer
Interval 2957.0 to 4780.0
|
3799 Titer
Interval 2995.0 to 4820.0
|
2777 Titer
Interval 2169.0 to 3556.0
|
4413 Titer
Interval 3409.0 to 5713.0
|
357 Titer
Interval 282.0 to 452.0
|
|
Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
6 months after vaccination on Day 1
|
—
|
1760 Titer
Interval 1372.0 to 2260.0
|
1883 Titer
Interval 1456.0 to 2435.0
|
1473 Titer
Interval 1188.0 to 1827.0
|
2523 Titer
Interval 1901.0 to 3348.0
|
301 Titer
Interval 241.0 to 377.0
|
SECONDARY outcome
Timeframe: At 14 days and 3 and 6 months after vaccination on Day 1Population: PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points.
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by enzyme-linked immunospot (ELISpot) assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\^6 PBMCs).
Outcome measures
| Measure |
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=50 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=48 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=25 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides
3 months after vaccination on Day 1
|
—
|
180 SFC/10^6 PBMCs
Interval to 1462.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
241 SFC/10^6 PBMCs
Interval to 906.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
168 SFC/10^6 PBMCs
Interval to 649.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
184 SFC/10^6 PBMCs
Interval to 737.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
NA SFC/10^6 PBMCs
Interval to 359.0
Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
|
|
Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides
14 days after vaccination on Day 1
|
—
|
547 SFC/10^6 PBMCs
Interval to 1426.0
Lower limit of full range could not be calculated as it was below the lower limit of quantification (LLOQ) (68)
|
458 SFC/10^6 PBMCs
Interval to 1721.0
Lower limit of full range could not be calculated as it was below the LLOQ (68)
|
397 SFC/10^6 PBMCs
Interval 79.0 to 1570.0
|
404 SFC/10^6 PBMCs
Interval 87.0 to 1579.0
|
NA SFC/10^6 PBMCs
Interval to 387.0
Median lower limit of full range could not be calculated as it was below the LLOQ (68)
|
|
Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides
6 months after vaccination on Day 1
|
—
|
129 SFC/10^6 PBMCs
Interval to 1631.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
189 SFC/10^6 PBMCs
Interval to 991.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
146 SFC/10^6 PBMCs
Interval to 636.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
127 SFC/10^6 PBMCs
Interval to 439.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
NA SFC/10^6 PBMCs
Interval to 266.0
Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
|
SECONDARY outcome
Timeframe: Baseline (Day1) up to 6 monthsPopulation: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
Outcome measures
| Measure |
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=48 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=25 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
|
—
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Until 7 days after vaccination on Day 1 (Day 8)Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Outcome measures
| Measure |
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=50 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=47 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=25 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
|
—
|
33 Participants
|
24 Participants
|
15 Participants
|
18 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Until 7 days after vaccination on Day 1 (Day 8)Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature \>=38 degree celsius).
Outcome measures
| Measure |
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=50 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=47 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=25 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
|
—
|
35 Participants
|
25 Participants
|
13 Participants
|
15 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Until 28 days after vaccination on Day 1 (Day 29)Population: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
Outcome measures
| Measure |
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=51 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=48 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=25 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
|
—
|
11 Participants
|
9 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 14 days and 3 and 6 months after vaccination on Day 1Population: PPI set was analyzed. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points. Due to change in planned analysis, data at 6-month was not collected and analyzed because of discontinuation of the development of the vaccine and hence, there was no scientific value to analyze the responses at Month 6.
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 14 days and 3 and 6 months after vaccination on Day 1 were reported.
Outcome measures
| Measure |
Cohort 3: Placebo
n=26 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=45 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=26 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=26 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=47 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1
14 days after vaccination on Day 1
|
298 EU/L
Interval 236.0 to 376.0
|
3769 EU/L
Interval 3006.0 to 4726.0
|
3893 EU/L
Interval 3243.0 to 4674.0
|
259 EU/L
Interval 201.0 to 333.0
|
4278 EU/L
Interval 3336.0 to 5486.0
|
3856 EU/L
Interval 3177.0 to 4682.0
|
|
Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1
3 months after vaccination on Day 1
|
339 EU/L
Interval 256.0 to 450.0
|
1982 EU/L
Interval 1627.0 to 2415.0
|
1665 EU/L
Interval 1162.0 to 2385.0
|
300 EU/L
Interval 244.0 to 369.0
|
2696 EU/L
Interval 1991.0 to 3651.0
|
1864 EU/L
Interval 1304.0 to 2664.0
|
SECONDARY outcome
Timeframe: At 14 days and 3 and 6 months after vaccination on Day 1Population: PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points.
RSV A2 neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% IC50 units.
Outcome measures
| Measure |
Cohort 3: Placebo
n=26 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=45 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=26 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=26 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=47 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
14 days after vaccination on Day 1
|
342 Titer
Interval 261.0 to 448.0
|
4102 Titer
Interval 3064.0 to 5491.0
|
3552 Titer
Interval 2635.0 to 4789.0
|
336 Titer
Interval 262.0 to 432.0
|
4085 Titer
Interval 3092.0 to 5398.0
|
3707 Titer
Interval 2841.0 to 4839.0
|
|
Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
3 months after vaccination on Day 1
|
490 Titer
Interval 344.0 to 698.0
|
3144 Titer
Interval 2537.0 to 3895.0
|
2556 Titer
Interval 1828.0 to 3575.0
|
371 Titer
Interval 282.0 to 488.0
|
3435 Titer
Interval 2714.0 to 4348.0
|
2671 Titer
Interval 1945.0 to 3669.0
|
|
Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
6 months after vaccination on Day 1
|
356 Titer
Interval 274.0 to 464.0
|
1983 Titer
Interval 1352.0 to 2909.0
|
1890 Titer
Interval 1460.0 to 2447.0
|
356 Titer
Interval 270.0 to 470.0
|
2168 Titer
Interval 1682.0 to 2794.0
|
1856 Titer
Interval 1509.0 to 2283.0
|
SECONDARY outcome
Timeframe: At 14 days and 3 and 6 months after vaccination on Day 1Population: PPI set was analyzed. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points. Due to change in planned analysis, data at 6-month was not collected and analyzed because of discontinuation of the development of the vaccine and hence, there was no scientific value to analyze the responses at Month 6.
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10\^6 PBMCs).
Outcome measures
| Measure |
Cohort 3: Placebo
n=24 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=40 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=42 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=22 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=25 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=45 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1
14 days after vaccination on Day 1
|
NA SFC/10^6 PBMCs
Interval to 216.0
Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
|
361 SFC/10^6 PBMCs
Interval to 1686.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
435 SFC/10^6 PBMCs
Interval 88.0 to 2088.0
|
NA SFC/10^6 PBMCs
Interval to 942.0
Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
|
236 SFC/10^6 PBMCs
Interval to 1764.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
204 SFC/10^6 PBMCs
Interval to 1888.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
|
Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1
3 months after vaccination on Day 1
|
NA SFC/10^6 PBMCs
Interval to 212.0
Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
|
331 SFC/10^6 PBMCs
Interval to 1287.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
274 SFC/10^6 PBMCs
Interval to 1831.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
NA SFC/10^6 PBMCs
Interval to 376.0
Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
|
131 SFC/10^6 PBMCs
Interval to 851.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
172 SFC/10^6 PBMCs
Interval to 2737.0
Lower limit of full range could not be calculated as it was below the LLOQ (68).
|
SECONDARY outcome
Timeframe: Baseline (Day1 ) up to 6 monthsPopulation: FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
Outcome measures
| Measure |
Cohort 3: Placebo
n=26 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=49 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=26 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=27 Participants
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=51 Participants
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Serious events: 2 serious events
Other events: 44 other events
Deaths: 1 deaths
Cohort 3: Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=51 participants at risk
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=51 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=51 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=48 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=25 participants at risk
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=49 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
n=49 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 2: Placebo
n=26 participants at risk
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=27 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
n=51 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 3: Placebo
n=26 participants at risk
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Covid-19
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Covid-19 Pneumonia
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Sepsis
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphoma
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
Other adverse events
| Measure |
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=51 participants at risk
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
n=51 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
n=51 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1\*10\^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
n=48 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7\*10\^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 1: Placebo
n=25 participants at risk
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=49 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
n=49 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 2: Placebo
n=26 participants at risk
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
n=27 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
n=51 participants at risk
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6\*10\^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
|
Cohort 3: Placebo
n=26 participants at risk
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Cystitis
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.9%
2/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Nausea
|
13.7%
7/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
11.8%
6/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.9%
2/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.0%
2/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
10.2%
5/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
26.5%
13/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
7.7%
2/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
22.2%
6/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
19.6%
10/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.7%
1/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Chills
|
5.9%
3/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
4.1%
2/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
7.4%
2/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.9%
2/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Fatigue
|
56.9%
29/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
31.4%
16/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
19.6%
10/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
25.0%
12/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
20.0%
5/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
65.3%
32/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
75.5%
37/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
15.4%
4/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
59.3%
16/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
66.7%
34/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
26.9%
7/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Injection Site Haemorrhage
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.7%
1/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Pyrexia
|
3.9%
2/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
12.2%
6/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
22.4%
11/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
14.8%
4/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
23.5%
12/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Swelling
|
3.9%
2/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
11.8%
6/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.9%
2/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
6.2%
3/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
14.3%
7/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
14.3%
7/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
7.4%
2/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
17.6%
9/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Swelling Face
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Tenderness
|
62.7%
32/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
45.1%
23/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
23.5%
12/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
35.4%
17/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
69.4%
34/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
81.6%
40/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
7.7%
2/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
85.2%
23/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
72.5%
37/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
7.7%
2/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Investigations
Blood Pressure Systolic Increased
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
41.2%
21/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
23.5%
12/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
7.8%
4/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
10.4%
5/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
4.0%
1/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
51.0%
25/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
59.2%
29/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
63.0%
17/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
45.1%
23/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
7.7%
2/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.7%
1/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Headache
|
35.3%
18/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
23.5%
12/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
11.8%
6/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
4.2%
2/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
12.0%
3/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
51.0%
25/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
51.0%
25/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
7.7%
2/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
55.6%
15/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
52.9%
27/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
11.5%
3/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Syncope
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Taste Disorder
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Nervous system disorders
Vith Nerve Paralysis
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Psychiatric disorders
Adjustment Disorder with Depressed Mood
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Symptom
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.8%
6/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
7.8%
4/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.9%
2/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
14.3%
7/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
14.3%
7/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
3.8%
1/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
7.4%
2/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
17.6%
9/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
4.0%
1/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Vascular disorders
Hypertension
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.1%
1/48 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/25 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
2.0%
1/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/49 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/27 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/51 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/26 • Baseline (Day 1) up to 6 months
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
|
Additional Information
CLINICAL FRANCHISE LEADER
Janssen Vaccines & Prevention B.V.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER