Trial Outcomes & Findings for Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005) (NCT NCT03635086)
NCT ID: NCT03635086
Last Updated: 2021-10-22
Results Overview
Participant serum was collected for determination of antibody responses by 50% plaque reduction neutralization test (PRNT50). Geometric Mean Titer (GMT) of functional antibodies as measured by PRNT50 were assessed. Geometric mean titers and GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2 sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey Kramer.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
28 days after last vaccination (Up to Day 56)
Results posted on
2021-10-22
Participant Flow
After completion of screening procedures, participants will be randomized to one of five treatment groups (A, B, C, D or E).
Participant milestones
| Measure |
Group A: Two Measles Virus-Chikungunya (MV-CHIK) Lyophilized Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
11
|
11
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group A: Two Measles Virus-Chikungunya (MV-CHIK) Lyophilized Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal of consent
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)
Baseline characteristics by cohort
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
n=12 Participants
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
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=8 Participants
|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 11.79 • n=7 Participants
|
39.0 years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 9.62 • n=4 Participants
|
36.8 years
STANDARD_DEVIATION 7.52 • n=21 Participants
|
36.9 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
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
|
60 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 28 days after last vaccination (Up to Day 56)Population: The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
Participant serum was collected for determination of antibody responses by 50% plaque reduction neutralization test (PRNT50). Geometric Mean Titer (GMT) of functional antibodies as measured by PRNT50 were assessed. Geometric mean titers and GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2 sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey Kramer.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
n=9 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
n=11 Participants
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by 50% Plaque Reduction Neutralization Test 28 Days After Last MV-CHIK Vaccination
|
21.0 Titer
Interval 9.9 to 44.5
|
19.1 Titer
Interval 9.0 to 40.5
|
13.6 Titer
Interval 5.9 to 31.2
|
45.7 Titer
Interval 21.6 to 97.0
|
8.9 Titer
Interval 4.2 to 18.8
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
An adverse event (AE) includes any untoward medical occurrence in a participant to whom an IMP has been administered, not necessarily caused by or related to that product. An AE can therefore be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease temporally associated with the use of an IMP whether or not considered related to the IMP. The percentage of participants with solicited and unsolicited AEs was assessed.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
n=12 Participants
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited and Unsolicited Adverse Events
|
83.3 Percentage of Participants
|
91.7 Percentage of Participants
|
58.3 Percentage of Participants
|
83.3 Percentage of Participants
|
91.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and consists of a congenital anomaly, birth defect or other important medical events. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
n=12 Participants
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1 Serious Adverse Event
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Day 365Population: The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
Participant serum was collected at each visit (Day 0, 28, 56, 182, and 365) for determination of antibody response by PRNT50. These results represent geometric mean titers (titers \<10 were set to 5 for protocol-specified analysis).
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
n=10 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
n=11 Participants
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
Day 0
|
5.0 Titer
Interval 3.0 to 8.2
|
8.6 Titer
Interval 5.3 to 14.2
|
5.0 Titer
Interval 3.0 to 8.4
|
5.0 Titer
Interval 3.0 to 8.2
|
5.0 Titer
Interval 3.0 to 8.2
|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
Day 28
|
7.2 Titer
Interval 3.9 to 13.2
|
14.0 Titer
Interval 7.6 to 25.6
|
6.3 Titer
Interval 3.4 to 11.9
|
11.3 Titer
Interval 6.2 to 20.8
|
8.9 Titer
Interval 4.8 to 16.2
|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
Day 56
|
21.0 Titer
Interval 10.1 to 43.7
|
19.1 Titer
Interval 9.2 to 39.7
|
13.6 Titer
Interval 6.0 to 30.5
|
45.7 Titer
Interval 22.0 to 95.2
|
6.9 Titer
Interval 3.3 to 14.3
|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
Day 182
|
13.8 Titer
Interval 7.0 to 27.2
|
18.2 Titer
Interval 9.2 to 35.9
|
10.5 Titer
Interval 5.1 to 21.5
|
11.8 Titer
Interval 6.0 to 23.4
|
6.8 Titer
Interval 3.4 to 13.5
|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies as Measured by PRNT50
Day 365
|
7.2 Titer
Interval 3.9 to 13.6
|
11.8 Titer
Interval 6.5 to 21.5
|
8.9 Titer
Interval 4.6 to 17.2
|
8.3 Titer
Interval 4.6 to 15.0
|
5.0 Titer
Interval 2.8 to 9.1
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells
CD4+CD69+ (Day 0)
|
0.0194 Percentage of t-cells
Standard Deviation 0.0446
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells
CD4+CD69+ (Day 14)
|
0.1430 Percentage of t-cells
Standard Deviation 0.1589
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells
CD4+CD69+ (Day 28)
|
0.1077 Percentage of t-cells
Standard Deviation 0.2060
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells
CD4+CD69+ (Day 42)
|
0.2050 Percentage of t-cells
Standard Deviation 0.2316
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+ Chikungunya Virus Specific T-Cells
CD4+CD69+ (Day 56)
|
0.1935 Percentage of t-cells
Standard Deviation 0.2036
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, a subset of the participants in treatment group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells
CD4+CD69+CD137+ (Day 0)
|
0.0061 Percentage of t-cells
Standard Deviation 0.0112
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells
CD4+CD69+CD137+ (Day 14)
|
0.0174 Percentage of t-cells
Standard Deviation 0.0313
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells
CD4+CD69+CD137+ (Day 28)
|
0.0120 Percentage of t-cells
Standard Deviation 0.0168
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells
CD4+CD69+CD137+ (Day 42)
|
0.0317 Percentage of t-cells
Standard Deviation 0.0438
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+CD137+ Chikungunya Virus Specific T-Cells
CD4+CD69+CD137+ (Day 56)
|
0.0393 Percentage of t-cells
Standard Deviation 0.0476
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells
CD4+CD137+ (Day 0)
|
0.0528 Percentage of t-cells
Standard Deviation 0.0509
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells
CD4+CD137+ (Day 14)
|
0.1595 Percentage of t-cells
Standard Deviation 0.2105
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells
CD4+CD137+ (Day 28)
|
0.1492 Percentage of t-cells
Standard Deviation 0.0932
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells
CD4+CD137+ (Day 42)
|
0.3484 Percentage of t-cells
Standard Deviation 0.3428
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD137+ Chikungunya Virus Specific T-Cells
CD4+CD137+ (Day 56)
|
0.3994 Percentage of t-cells
Standard Deviation 0.2713
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells
CD4+CD69+OX40+ (Day 0)
|
0.0033 Percentage of t-cells
Standard Deviation 0.0048
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells
CD4+CD69+OX40+ (Day 14)
|
0.0265 Percentage of t-cells
Standard Deviation 0.0522
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells
CD4+CD69+OX40+ (Day 28)
|
0.0095 Percentage of t-cells
Standard Deviation 0.0070
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells
CD4+CD69+OX40+ (Day 42)
|
0.0267 Percentage of t-cells
Standard Deviation 0.0408
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+CD69+OX40+ Chikungunya Virus Specific T-Cells
CD4+CD69+OX40+ (Day 56)
|
0.0337 Percentage of t-cells
Standard Deviation 0.0386
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
Cellular immunogenicity will be determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of subjects.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells
CD4+OX40+ (Day 0)
|
0.0062 Percentage of t-cells
Standard Deviation 0.0158
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells
CD4+OX40+ (Day 14)
|
0.0745 Percentage of t-cells
Standard Deviation 0.1007
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells
CD4+OX40+ (Day 28)
|
0.0269 Percentage of t-cells
Standard Deviation 0.0280
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells
CD4+OX40+ (Day 42)
|
0.0492 Percentage of t-cells
Standard Deviation 0.1012
|
—
|
—
|
—
|
—
|
|
Percentage of CD4+OX40+ Chikungunya Virus Specific T-Cells
CD4+OX40+ (Day 56)
|
0.0698 Percentage of t-cells
Standard Deviation 0.0997
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells
CD8+CD69+ (Day 0)
|
0.1919 Percentage of t-cells
Standard Deviation 0.2329
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells
CD8+CD69+ (Day 14)
|
0.3319 Percentage of t-cells
Standard Deviation 0.6046
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells
CD8+CD69+ (Day 28)
|
0.4242 Percentage of t-cells
Standard Deviation 0.6330
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells
CD8+CD69+ (Day 42)
|
0.1961 Percentage of t-cells
Standard Deviation 0.2496
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD69+ Chikungunya Virus Specific T-Cells
CD8+CD69+ (Day 56)
|
0.2375 Percentage of t-cells
Standard Deviation 0.2902
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells
CD8+CD69+CD137+ (Day 0)
|
0.0005 Percentage of t-cells
Standard Deviation 0.0018
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells
CD8+CD69+CD137+ (Day 14)
|
0.0139 Percentage of t-cells
Standard Deviation 0.0229
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells
CD8+CD69+CD137+ (Day 28)
|
0.0184 Percentage of t-cells
Standard Deviation 0.0454
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells
CD8+CD69+CD137+ (Day 42)
|
0.0148 Percentage of t-cells
Standard Deviation 0.0171
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD69+CD137+ Chikungunya Virus Specific T-Cells
CD8+CD69+CD137+ (Day 56)
|
0.0380 Percentage of t-cells
Standard Deviation 0.0392
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included a subset of all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response. Based on the protocol, only participants in subset Treatment Group D (MV-CHIK liquid frozen high dose formulation) were analyzed for t-cell response.
Cellular immunogenicity was determined by the evaluation of T cell immune response. Blood was collected for the isolation of peripheral blood mononuclear cells (PBMCs). PBMCs were isolated from whole blood to determine functional Interleukin 2 (IL-2)-producing T cells on day 0, 14, 28, 42, and 56 and in a subset of participants.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells
CD8+CD137+ (Day 0)
|
0.0194 Percentage of t-cells
Standard Deviation 0.0334
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells
CD8+CD137+ (Day 14)
|
0.0294 Percentage of t-cells
Standard Deviation 0.0366
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells
CD8+CD137+ (Day 28)
|
0.0224 Percentage of t-cells
Standard Deviation 0.0377
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells
CD8+CD137+ (Day 42)
|
0.0341 Percentage of t-cells
Standard Deviation 0.0595
|
—
|
—
|
—
|
—
|
|
Percentage of CD8+CD137+ Chikungunya Virus Specific T-Cells
CD8+CD137+ (Day 56)
|
0.0607 Percentage of t-cells
Standard Deviation 0.0557
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 365Population: The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
Participant serum was collected at each visit (Day 0, 28, 56, 182, and 365) for determination of Chikungunya antibody response by enzyme linked immunosorbent assay (ELISA). The analysis of variance GMT of Chikungunya-ELISA antibodies between treatment groups is summarized.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
n=10 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
n=11 Participants
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
Day 0
|
7.4 Titer
Standard Deviation 0.0
|
14.5 Titer
Standard Deviation 3907.50
|
7.4 Titer
Standard Deviation 0.0
|
7.4 Titer
Standard Deviation 0.0
|
7.4 Titer
Standard Deviation 0.0
|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
Day 28
|
9.7 Titer
Standard Deviation 46.83
|
17.8 Titer
Standard Deviation 4009.38
|
8.1 Titer
Standard Deviation 3.69
|
14.1 Titer
Standard Deviation 28.47
|
13.1 Titer
Standard Deviation 8.74
|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
Day 56
|
54.3 Titer
Standard Deviation 306.39
|
90.0 Titer
Standard Deviation 4369.43
|
54.7 Titer
Standard Deviation 112.29
|
171.4 Titer
Standard Deviation 307.41
|
9.8 Titer
Standard Deviation 7.69
|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
Day 182
|
15.6 Titer
Standard Deviation 112.90
|
26.9 Titer
Standard Deviation 3304.35
|
16.3 Titer
Standard Deviation 92.58
|
26.5 Titer
Standard Deviation 17.36
|
8.1 Titer
Standard Deviation 4.66
|
|
Geometric Mean Titer of Anti-Chikungunya Antibodies Determined by Enzyme Linked Immunosorbent Assay
Day 365
|
11.9 Titer
Standard Deviation 112.80
|
23.8 Titer
Standard Deviation 3087.93
|
15.8 Titer
Standard Deviation 75.39
|
18.9 Titer
Standard Deviation 18.52
|
9.4 Titer
Standard Deviation 10.01
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included all randomized participants who received at least one investigational medicinal product (IMP) administration and had no major protocol deviation that could have had an impact on their immune response.
Participant serum was collected at each visit (Day 0, 28, and 56) for determination of antibody responses by ELISA.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
n=10 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
n=11 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
n=11 Participants
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA
Day 0
|
711.6 Titer
Standard Deviation 1764.77
|
482.1 Titer
Standard Deviation 1009.40
|
750.2 Titer
Standard Deviation 1580.90
|
731.0 Titer
Standard Deviation 1612.98
|
888.4 Titer
Standard Deviation 1560.14
|
|
Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA
Day 28
|
1250.8 Titer
Standard Deviation 1629.35
|
1120.3 Titer
Standard Deviation 849.01
|
1207.7 Titer
Standard Deviation 1642.33
|
2246.4 Titer
Standard Deviation 1515.40
|
2116.2 Titer
Standard Deviation 1527.25
|
|
Geometric Mean Titer of Anti-Measles Antibodies Determined by ELISA
Day 56
|
1476.8 Titer
Standard Deviation 1672.10
|
1158.6 Titer
Standard Deviation 1019.59
|
1355.4 Titer
Standard Deviation 1818.08
|
3009.80 Titer
Standard Deviation 1355.67
|
2011.8 Titer
Standard Deviation 1852.26
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory hematology value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory hematology value.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
n=12 Participants
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Day 56Population: The analysis population included all participants who entered in the study and received at least one IMP administration. All analyses based on the safety population were carried out using the actual treatment received.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory chemistry value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory chemistry value.
Outcome measures
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
n=12 Participants
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
n=12 Participants
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Group A: Two MV-CHIK Lyophilized Low Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group B: Two MV-CHIK Liquid Frozen Low Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group D: Two MV-CHIK Liquid Frozen High Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group E: One MV-CHIK Liquid Frozen High Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: Two MV-CHIK Lyophilized Low Dose
n=12 participants at risk
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, lyophilized low dose (powder for suspension in water for intramuscular \[IM\] injection): 5x10\^4 ±0.5 log tissue culture infectious dose 50 (TCID50)/dose.
|
Group B: Two MV-CHIK Liquid Frozen Low Dose
n=12 participants at risk
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group C: Two MV-CHIK Liquid Low Dose Stabilizing and Protecting Solution (SPS®)
n=12 participants at risk
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid SPS® low dose (suspension for IM injection): 1x10\^5 ±0.5 log TCID50/dose.
|
Group D: Two MV-CHIK Liquid Frozen High Dose
n=12 participants at risk
Participants received two vaccinations (Day 0 and Day 28) with MV-CHIK, a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose.
|
Group E: One MV-CHIK Liquid Frozen High Dose
n=12 participants at risk
Participants received one vaccination (Day 0) with MV-CHIK a live-attenuated recombinant measles vaccine expressing Chikungunya virus antigens, liquid frozen high dose (suspension for IM injection): 1x10\^6 ±0.5 log TCID50/dose and placebo (Day 28), a sterile physiological saline solution (0.9% sodium chloride \[NaCl\]), administered by IM injection.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Eye disorders
Lacrimation increased
|
8.3%
1/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
25.0%
3/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
General disorders
Chills
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
25.0%
3/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
General disorders
Injection site erythema
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
General disorders
Injection site induration
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
25.0%
3/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
General disorders
Injection site pain
|
16.7%
2/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
25.0%
3/12 • Number of events 5 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
25.0%
3/12 • Number of events 6 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
66.7%
8/12 • Number of events 15 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
58.3%
7/12 • Number of events 7 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
General disorders
Injection site pruritus
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
25.0%
3/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
General disorders
Injection site swelling
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
25.0%
3/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
General disorders
Pain
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Investigations
White blood cell count decreased
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
16.7%
2/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Nervous system disorders
Headache
|
41.7%
5/12 • Number of events 8 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
41.7%
5/12 • Number of events 7 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
41.7%
5/12 • Number of events 7 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
41.7%
5/12 • Number of events 7 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
41.7%
5/12 • Number of events 6 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
25.0%
3/12 • Number of events 3 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
2/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
|
Vascular disorders
Pallor
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 2 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
8.3%
1/12 • Number of events 1 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
0.00%
0/12 • Serious and non-serious adverse events: Up to ~Day 56. All cause mortality: Up to ~Day 365.
The analysis population included all participants who entered in the study and received at least one IMP administration. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60