Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Participants (NCT NCT03325075)
NCT ID: NCT03325075
Last Updated: 2024-06-10
Results Overview
Solicited AEs, including local and systemic AEs were recorded by participants daily using the memory aid. Solicited local AEs include injection site induration/swelling, injection site tenderness, injection site erythema/redness, and injection site pain. Solicited systemic AEs include body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, and diarrhea. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
7 days following each vaccination
Results posted on
2024-06-10
Participant Flow
Participant milestones
| Measure |
VAL-181388 Dose A
Participants received 2 intramuscular (IM) injections of VAL-181388 Dose A separated by 28 days.
|
VAL-181388 Dose B
Participants received 2 IM injections of VAL-181388 Dose B separated by 28 days.
|
VAL-181388 Dose C
Participants received 2 IM injections of VAL-181388 Dose C separated by 28 days.
|
Placebo
Participants received 2 IM injections of VAL-181388 matched placebo separated by 28 days.
|
|---|---|---|---|---|
|
Part A: Dose Escalation (28 Days)
STARTED
|
15
|
15
|
15
|
15
|
|
Part A: Dose Escalation (28 Days)
Received Vaccination 1
|
15
|
15
|
15
|
15
|
|
Part A: Dose Escalation (28 Days)
Received Vaccination 2
|
15
|
14
|
14
|
15
|
|
Part A: Dose Escalation (28 Days)
COMPLETED
|
15
|
15
|
15
|
15
|
|
Part A: Dose Escalation (28 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part B: Follow-up (Up to 364 Days)
STARTED
|
15
|
15
|
15
|
15
|
|
Part B: Follow-up (Up to 364 Days)
COMPLETED
|
13
|
13
|
15
|
13
|
|
Part B: Follow-up (Up to 364 Days)
NOT COMPLETED
|
2
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
VAL-181388 Dose A
Participants received 2 intramuscular (IM) injections of VAL-181388 Dose A separated by 28 days.
|
VAL-181388 Dose B
Participants received 2 IM injections of VAL-181388 Dose B separated by 28 days.
|
VAL-181388 Dose C
Participants received 2 IM injections of VAL-181388 Dose C separated by 28 days.
|
Placebo
Participants received 2 IM injections of VAL-181388 matched placebo separated by 28 days.
|
|---|---|---|---|---|
|
Part B: Follow-up (Up to 364 Days)
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Part B: Follow-up (Up to 364 Days)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Part B: Follow-up (Up to 364 Days)
Other than specified
|
0
|
1
|
0
|
2
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Participants
Baseline characteristics by cohort
| Measure |
VAL-181388 Dose A
n=15 Participants
Participants received 2 IM injections of VAL-181388 Dose A separated by 28 days.
|
VAL-181388 Dose B
n=15 Participants
Participants received 2 IM injections of VAL-181388 Dose B separated by 28 days.
|
VAL-181388 Dose C
n=15 Participants
Participants received 2 IM injections of VAL-181388 Dose C separated by 28 days.
|
Placebo
n=15 Participants
Participants received 2 IM injections of VAL-181388 matched placebo separated by 28 days.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 8.45 • n=99 Participants
|
33.0 years
STANDARD_DEVIATION 6.76 • n=107 Participants
|
32.2 years
STANDARD_DEVIATION 8.46 • n=206 Participants
|
29.1 years
STANDARD_DEVIATION 5.18 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 7.30 • n=31 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
53 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 7 days following each vaccinationPopulation: The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo). Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Solicited AEs, including local and systemic AEs were recorded by participants daily using the memory aid. Solicited local AEs include injection site induration/swelling, injection site tenderness, injection site erythema/redness, and injection site pain. Solicited systemic AEs include body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, and diarrhea. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
VAL-181388 Dose A: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 Dose A.
|
VAL-181388 Dose A: Vaccination 2
n=15 Participants
Participants received second IM injection of VAL-181388 Dose A.
|
VAL-181388 Dose B: Vaccination 1
n=14 Participants
Participants received first IM injection of VAL-181388 Dose B.
|
VAL-181388 Dose B: Vaccination 2
n=13 Participants
Participants received second IM injection of VAL-181388 Dose B.
|
VAL-181388 Dose C: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 Dose C.
|
VAL-181388 Dose C: Vaccination 2
n=14 Participants
Participants received second IM injection of VAL-181388 Dose C.
|
Placebo: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 matched placebo.
|
Placebo: Vaccination 2
n=15 Participants
Participants received second IM injection of VAL-181388 matched placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events)
|
11 Participants
|
10 Participants
|
11 Participants
|
10 Participants
|
13 Participants
|
12 Participants
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 28 days following each vaccinationPopulation: The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
VAL-181388 Dose A: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 Dose A.
|
VAL-181388 Dose A: Vaccination 2
n=15 Participants
Participants received second IM injection of VAL-181388 Dose A.
|
VAL-181388 Dose B: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 Dose B.
|
VAL-181388 Dose B: Vaccination 2
n=14 Participants
Participants received second IM injection of VAL-181388 Dose B.
|
VAL-181388 Dose C: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 Dose C.
|
VAL-181388 Dose C: Vaccination 2
n=14 Participants
Participants received second IM injection of VAL-181388 Dose C.
|
Placebo: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 matched placebo.
|
Placebo: Vaccination 2
n=15 Participants
Participants received second IM injection of VAL-181388 matched placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Unsolicited AEs
|
4 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 28 days following each vaccinationPopulation: The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
VAL-181388 Dose A: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 Dose A.
|
VAL-181388 Dose A: Vaccination 2
n=15 Participants
Participants received second IM injection of VAL-181388 Dose A.
|
VAL-181388 Dose B: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 Dose B.
|
VAL-181388 Dose B: Vaccination 2
n=14 Participants
Participants received second IM injection of VAL-181388 Dose B.
|
VAL-181388 Dose C: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 Dose C.
|
VAL-181388 Dose C: Vaccination 2
n=14 Participants
Participants received second IM injection of VAL-181388 Dose C.
|
Placebo: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 matched placebo.
|
Placebo: Vaccination 2
n=15 Participants
Participants received second IM injection of VAL-181388 matched placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest
Medically-Attended AEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest
AEs of Special Interest
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through 1 year following the last vaccinationPopulation: The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
VAL-181388 Dose A: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 Dose A.
|
VAL-181388 Dose A: Vaccination 2
n=15 Participants
Participants received second IM injection of VAL-181388 Dose A.
|
VAL-181388 Dose B: Vaccination 1
n=15 Participants
Participants received first IM injection of VAL-181388 Dose B.
|
VAL-181388 Dose B: Vaccination 2
n=15 Participants
Participants received second IM injection of VAL-181388 Dose B.
|
VAL-181388 Dose C: Vaccination 1
Participants received first IM injection of VAL-181388 Dose C.
|
VAL-181388 Dose C: Vaccination 2
Participants received second IM injection of VAL-181388 Dose C.
|
Placebo: Vaccination 1
Participants received first IM injection of VAL-181388 matched placebo.
|
Placebo: Vaccination 2
Participants received second IM injection of VAL-181388 matched placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With SAEs and AEs of Special Interest
SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With SAEs and AEs of Special Interest
AEs of Special Interest
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Part A - VAL-181388 Dose A: Vaccination 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A - VAL-181388 Dose A: Vaccination 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - VAL-181388 Dose B: Vaccination 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A - VAL-181388 Dose B: Vaccination 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - VAL-181388 Dose C: Vaccination 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A - VAL-181388 Dose C: Vaccination 2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A - Placebo: Vaccination 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A - Placebo: Vaccination 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B - VAL-181388 Dose A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B - VAL-181388 Dose B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B - VAL-181388 Dose C
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A - VAL-181388 Dose A: Vaccination 1
n=15 participants at risk
Participants received first IM injection of VAL-181388 Dose A.
|
Part A - VAL-181388 Dose A: Vaccination 2
n=15 participants at risk
Participants received second IM injection of VAL-181388 Dose A.
|
Part A - VAL-181388 Dose B: Vaccination 1
n=15 participants at risk
Participants received first IM injection of VAL-181388 Dose B.
|
Part A - VAL-181388 Dose B: Vaccination 2
n=14 participants at risk
Participants received second IM injection of VAL-181388 Dose B.
|
Part A - VAL-181388 Dose C: Vaccination 1
n=15 participants at risk
Participants received first IM injection of VAL-181388 Dose C.
|
Part A - VAL-181388 Dose C: Vaccination 2
n=14 participants at risk
Participants received second IM injection of VAL-181388 Dose C.
|
Part A - Placebo: Vaccination 1
n=15 participants at risk
Participants received first IM injection of VAL-181388 matched placebo.
|
Part A - Placebo: Vaccination 2
n=15 participants at risk
Participants received second IM injection of VAL-181388 matched placebo.
|
Part B - VAL-181388 Dose A
n=15 participants at risk
Participants who received VAL-181388 Dose A in Part A, were followed up for longer-term safety and immune persistence in Part B.
|
Part B - VAL-181388 Dose B
n=15 participants at risk
Participants who received VAL-181388 Dose B in Part A, were followed up for longer-term safety and immune persistence in Part B.
|
Part B - VAL-181388 Dose C
n=15 participants at risk
Participants who received VAL-181388 Dose C in Part A, were followed up for longer-term safety and immune persistence in Part B.
|
Part B - Placebo
n=15 participants at risk
Participants who received VAL-181388 matched placebo in Part A, were followed up for longer-term safety and immune persistence in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
Other adverse events
| Measure |
Part A - VAL-181388 Dose A: Vaccination 1
n=15 participants at risk
Participants received first IM injection of VAL-181388 Dose A.
|
Part A - VAL-181388 Dose A: Vaccination 2
n=15 participants at risk
Participants received second IM injection of VAL-181388 Dose A.
|
Part A - VAL-181388 Dose B: Vaccination 1
n=15 participants at risk
Participants received first IM injection of VAL-181388 Dose B.
|
Part A - VAL-181388 Dose B: Vaccination 2
n=14 participants at risk
Participants received second IM injection of VAL-181388 Dose B.
|
Part A - VAL-181388 Dose C: Vaccination 1
n=15 participants at risk
Participants received first IM injection of VAL-181388 Dose C.
|
Part A - VAL-181388 Dose C: Vaccination 2
n=14 participants at risk
Participants received second IM injection of VAL-181388 Dose C.
|
Part A - Placebo: Vaccination 1
n=15 participants at risk
Participants received first IM injection of VAL-181388 matched placebo.
|
Part A - Placebo: Vaccination 2
n=15 participants at risk
Participants received second IM injection of VAL-181388 matched placebo.
|
Part B - VAL-181388 Dose A
n=15 participants at risk
Participants who received VAL-181388 Dose A in Part A, were followed up for longer-term safety and immune persistence in Part B.
|
Part B - VAL-181388 Dose B
n=15 participants at risk
Participants who received VAL-181388 Dose B in Part A, were followed up for longer-term safety and immune persistence in Part B.
|
Part B - VAL-181388 Dose C
n=15 participants at risk
Participants who received VAL-181388 Dose C in Part A, were followed up for longer-term safety and immune persistence in Part B.
|
Part B - Placebo
n=15 participants at risk
Participants who received VAL-181388 matched placebo in Part A, were followed up for longer-term safety and immune persistence in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
2/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
20.0%
3/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Infections and infestations
Vaginal infection
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
13.3%
2/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
General disorders
Fatigue
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
General disorders
Injection site rash
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Investigations
Amylase increased
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Investigations
Lipase increased
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Investigations
Blood pressure increased
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
13.3%
2/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Eye disorders
Blepharospasm
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
6.7%
1/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
7.1%
1/14 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
0.00%
0/15 • Through 1 year following the last vaccination
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
|
Additional Information
Moderna Clinical Trials Support Center
ModernaTX, Inc.
Phone: 1-877-777-7187
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place