Trial Outcomes & Findings for A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older (NCT NCT05327816)
NCT ID: NCT05327816
Last Updated: 2025-05-25
Results Overview
An AE is 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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
132 participants
Primary outcome timeframe
From Day 1 up to 6 months post vaccination (up to Day 183)
Results posted on
2025-05-25
Participant Flow
Study was terminated on sponsor's decision, hence, participants were enrolled in Cohort 1 only. Cohorts 2, 3, and 4 were not initiated. Participants enrolled in Cohort 1 completed visit up to Day 183 (6-months post vaccination) and safety evaluations were performed only for Cohort 1. Since the study was terminated prior to Cohort 2 enrolment and the data was planned for combined Cohorts 1 and 2, samples collected in Cohort 1 alone were not tested and no immunogenicity testing was performed.
Participant milestones
| Measure |
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg
Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1\*10\^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1.
|
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1\*10\^11 vp and RSV-A.preF protein 150 mcg on Day 1.
|
Arm 1c (Cohort 1): Pooled Placebo
Participants received a single IM injection of placebo on Day 1.
|
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg
Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
Participants received single IM injections of Ad26.RSV-A.preF 2.5\*10\^10 vp, Ad26.RSV-B.preF2 2.5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg
Participants received single IM injections of Ad26.RSV-A.preF 5\*10\^10 vp, Ad26.RSV-B.preF2 5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 5\*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg
Participants received single IM injections of Ad26.RSV-A.preF 1.5\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
|
Overall Study
Treated (Full Analysis Set)
|
12
|
12
|
12
|
12
|
12
|
12
|
11
|
11
|
11
|
12
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
12
|
Reasons for withdrawal
| Measure |
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg
Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1\*10\^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1.
|
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1\*10\^11 vp and RSV-A.preF protein 150 mcg on Day 1.
|
Arm 1c (Cohort 1): Pooled Placebo
Participants received a single IM injection of placebo on Day 1.
|
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg
Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
Participants received single IM injections of Ad26.RSV-A.preF 2.5\*10\^10 vp, Ad26.RSV-B.preF2 2.5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg
Participants received single IM injections of Ad26.RSV-A.preF 5\*10\^10 vp, Ad26.RSV-B.preF2 5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 5\*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg
Participants received single IM injections of Ad26.RSV-A.preF 1.5\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
11
|
12
|
12
|
12
|
11
|
11
|
11
|
11
|
11
|
11
|
12
|
|
Overall Study
Randomized but not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older
Baseline characteristics by cohort
| Measure |
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg
n=12 Participants
Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1\*10\^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1.
|
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg
n=12 Participants
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1\*10\^11 vp and RSV-A.preF protein 150 mcg on Day 1.
|
Arm 1c (Cohort 1): Pooled Placebo
n=12 Participants
Participants received a single IM injection of placebo on Day 1.
|
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg
n=12 Participants
Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 2.5\*10\^10 vp, Ad26.RSV-B.preF2 2.5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 5\*10\^10 vp, Ad26.RSV-B.preF2 5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 5\*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1.5\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 5.42 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 5.01 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 5.65 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 3.39 • n=4 Participants
|
65.7 years
STANDARD_DEVIATION 4.94 • n=21 Participants
|
67.4 years
STANDARD_DEVIATION 4.83 • n=10 Participants
|
68.5 years
STANDARD_DEVIATION 6.12 • n=115 Participants
|
64.8 years
STANDARD_DEVIATION 4.14 • n=24 Participants
|
66.3 years
STANDARD_DEVIATION 3.04 • n=42 Participants
|
65.4 years
STANDARD_DEVIATION 4.4 • n=42 Participants
|
65.5 years
STANDARD_DEVIATION 3.78 • n=42 Participants
|
66.9 years
STANDARD_DEVIATION 4.76 • n=42 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
77 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
122 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=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)
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
|
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
|
1 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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
109 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
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)
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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
11 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
129 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 6 months post vaccination (up to Day 183)Population: The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
An AE is 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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Outcome measures
| Measure |
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg
n=12 Participants
Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1\*10\^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1.
|
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg
n=12 Participants
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1\*10\^11 vp and RSV-A.preF protein 150 mcg on Day 1.
|
Arm 1c (Cohort 1): Pooled Placebo
n=12 Participants
Participants received a single IM injection of placebo on Day 1.
|
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg
n=12 Participants
Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 2.5\*10\^10 vp, Ad26.RSV-B.preF2 2.5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 5\*10\^10 vp, Ad26.RSV-B.preF2 5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 5\*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1.5\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 6 months post vaccination (up to Day 183)Population: The FAS included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
Number of participants with AESIs were reported. Thrombosis with thrombocytopenia syndrome (TTS) were considered as potential AESIs.
Outcome measures
| Measure |
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg
n=12 Participants
Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1\*10\^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1.
|
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg
n=12 Participants
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1\*10\^11 vp and RSV-A.preF protein 150 mcg on Day 1.
|
Arm 1c (Cohort 1): Pooled Placebo
n=12 Participants
Participants received a single IM injection of placebo on Day 1.
|
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg
n=12 Participants
Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 2.5\*10\^10 vp, Ad26.RSV-B.preF2 2.5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 5\*10\^10 vp, Ad26.RSV-B.preF2 5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 5\*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1.5\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days post vaccination (Day 8)Population: The FAS included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
Number of participants with solicited local and systemic AEs were reported. An AE is 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 that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Outcome measures
| Measure |
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg
n=12 Participants
Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1\*10\^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1.
|
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg
n=12 Participants
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1\*10\^11 vp and RSV-A.preF protein 150 mcg on Day 1.
|
Arm 1c (Cohort 1): Pooled Placebo
n=12 Participants
Participants received a single IM injection of placebo on Day 1.
|
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg
n=12 Participants
Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 2.5\*10\^10 vp, Ad26.RSV-B.preF2 2.5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 5\*10\^10 vp, Ad26.RSV-B.preF2 5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 5\*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1.5\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs)
Solicited Systemic AEs
|
9 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
7 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AEs)
Solicited Local AEs
|
6 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
11 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 28 days post vaccination (Day 29)Population: The FAS included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
Number of participants with unsolicited AEs were reported. An AE is 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 are all AEs for which the participant were not specifically questioned in the participant diary.
Outcome measures
| Measure |
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg
n=12 Participants
Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1\*10\^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1.
|
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg
n=12 Participants
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1\*10\^11 vp and RSV-A.preF protein 150 mcg on Day 1.
|
Arm 1c (Cohort 1): Pooled Placebo
n=12 Participants
Participants received a single IM injection of placebo on Day 1.
|
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg
n=12 Participants
Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 2.5\*10\^10 vp, Ad26.RSV-B.preF2 2.5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 5\*10\^10 vp, Ad26.RSV-B.preF2 5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg
n=11 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 5\*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1.5\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 Participants
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AEs)
|
5 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
Adverse Events
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm 1c (Cohort 1): Pooled Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg
n=12 participants at risk
Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1\*10\^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1.
|
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg
n=12 participants at risk
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1\*10\^11 vp and RSV-A.preF protein 150 mcg on Day 1.
|
Arm 1c (Cohort 1): Pooled Placebo
n=12 participants at risk
Participants received a single IM injection of placebo on Day 1.
|
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg
n=12 participants at risk
Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 2.5\*10\^10 vp, Ad26.RSV-B.preF2 2.5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg
n=12 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 5\*10\^10 vp, Ad26.RSV-B.preF2 5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg
n=11 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg
n=11 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg
n=11 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 5\*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg
n=12 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 1.5\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
Other adverse events
| Measure |
Arm 1a (Cohort 1): Ad26.RSV-B.PreF2 1*10^11 vp + RSV-B.PreF Protein 150 mcg
n=12 participants at risk
Participants received single intramuscular (IM) injections of adenovirus serotype 26 respiratory syncytial virus-B prefusion-F2 protein (Ad26.RSV-B.preF2) 1\*10\^11 viral particles (vp) and RSV-B.preF protein 150 micrograms (mcg) on Day 1.
|
Arm 1b (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 150 mcg
n=12 participants at risk
Participants received single IM injections of adenovirus serotype 26 respiratory syncytial virus-A prefusion-F protein (Ad26.RSV-A.preF) 1\*10\^11 vp and RSV-A.preF protein 150 mcg on Day 1.
|
Arm 1c (Cohort 1): Pooled Placebo
n=12 participants at risk
Participants received a single IM injection of placebo on Day 1.
|
Arm 2 (Cohort 1): RSV-A.PreF Protein 150 mcg + RSV-B.PreF Protein 150 mcg
n=12 participants at risk
Participants received single IM injections of RSV-A.preF protein 150 mcg and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 3 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 2.5*10^10 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 2.5\*10\^10 vp, Ad26.RSV-B.preF2 2.5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 4 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 5*10^10 vp + RSV-A.PreF /RSV-B.PreF 150 mcg
n=12 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 5\*10\^10 vp, Ad26.RSV-B.preF2 5 \*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 5 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF Protein 300 mcg
n=11 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 6 (Cohort 1): Ad26.RSV-A.PreF 1*10^11 vp + RSV-A.PreF and RSV-B.PreF at 150 mcg
n=11 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 7 (Cohort 1):Ad26.RSV-A.PreF 1*10^11vp/Ad26.RSV-B.preF2 5*10^10vp + RSV-A.Pre/RSV-B.PreF 150 mcg
n=11 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 5\*10\^10 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
Arm 8 (Cohort 1): Ad26.RSV-A.PreF 1.5*10^11 vp +RSV-A.PreF Protein 300 mcg
n=12 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 1.5\*10\^11 vp and RSV-A.preF protein 300 mcg on Day 1.
|
Arm 9 (Cohort 1): Ad26.RSV-A.PreF/Ad26.RSV-B.preF2 1*10^11 vp + RSV-A.PreF/RSV-B.PreF 150 mcg
n=12 participants at risk
Participants received single IM injections of Ad26.RSV-A.preF 1\*10\^11 vp, Ad26.RSV-B.preF2 1\*10\^11 vp, RSV-A.preF protein 150 mcg, and RSV-B.preF protein 150 mcg on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
41.7%
5/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
50.0%
6/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
41.7%
5/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
25.0%
3/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
33.3%
4/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
33.3%
4/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
54.5%
6/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
72.7%
8/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
72.7%
8/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
58.3%
7/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
25.0%
3/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
58.3%
7/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
58.3%
7/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
33.3%
4/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
50.0%
6/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
66.7%
8/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
66.7%
8/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
54.5%
6/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
81.8%
9/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
72.7%
8/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
75.0%
9/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
50.0%
6/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
25.0%
3/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
16.7%
2/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
25.0%
3/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
33.3%
4/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
25.0%
3/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
36.4%
4/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
27.3%
3/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
27.3%
3/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
33.3%
4/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Chills
|
16.7%
2/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
41.7%
5/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Fatigue
|
50.0%
6/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
58.3%
7/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
50.0%
6/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
41.7%
5/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
58.3%
7/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
66.7%
8/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
45.5%
5/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
81.8%
9/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
72.7%
8/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
83.3%
10/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
58.3%
7/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Injection Site Bruising
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Pyrexia
|
16.7%
2/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
16.7%
2/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
25.0%
3/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
18.2%
2/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
45.5%
5/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
25.0%
3/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
16.7%
2/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Swelling
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
General disorders
Tenderness
|
50.0%
6/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
66.7%
8/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
41.7%
5/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
58.3%
7/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
66.7%
8/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
83.3%
10/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
63.6%
7/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
72.7%
8/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
81.8%
9/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
91.7%
11/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
58.3%
7/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Covid-19
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Tinea Pedis
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Investigations
Blood Urea Increased
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Investigations
Neutrophil Count Increased
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
16.7%
2/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
9.1%
1/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/11 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
0.00%
0/12 • From Day 1 up to 6 months post vaccination (up to Day 183)
The full analysis set (FAS) included all participants who received the study vaccine, regardless of the occurrence of protocol deviations.
|
Additional Information
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 to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER