Trial Outcomes & Findings for Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever (NCT NCT02116205)
NCT ID: NCT02116205
Last Updated: 2021-02-12
Results Overview
The primary endpoint will be to determine the seroconversion rates of the vaccines. Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). A PsVNA50 titer ≥ 20 is considered positive. Sera were collected on Days 0, 28, 56, 84, 140, 168, 196, 252, 365 and evaluated for the presence of neutralizing antibodies using PsVNA50. Percentages for seroconversion are based on the number of subjects presenting non-missing data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Study Days 0 to 365
Results posted on
2021-02-12
Participant Flow
A total of 130 subjects were enrolled in the study. Ten of the 130 were enrolled as replacements for early withdrawals. The first participant was enrolled on July 9, 2014 and the last participant was enrolled in September 2015.
Participant milestones
| Measure |
Vaccine + Placebo at 1.0 mg
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 1.0 mg
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine + Placebo at 2.0 mg
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 2.0 mg
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
33
|
33
|
|
Overall Study
COMPLETED
|
29
|
26
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
4
|
6
|
Reasons for withdrawal
| Measure |
Vaccine + Placebo at 1.0 mg
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 1.0 mg
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine + Placebo at 2.0 mg
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 2.0 mg
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
1
|
|
Overall Study
Exclusion criteria
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever
Baseline characteristics by cohort
| Measure |
Vaccine + Placebo at 1.0 mg
n=31 Participants
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 1.0 mg
n=33 Participants
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine + Placebo at 2.0 mg
n=33 Participants
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 2.0 mg
n=33 Participants
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
Age
|
34.3 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
30.9 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
30.5 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
33.2 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
32.2 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
119 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
33 participants
n=7 Participants
|
33 participants
n=5 Participants
|
33 participants
n=4 Participants
|
130 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Study Days 0 to 365Population: Of the 130 subjects enrolled, 120 met the conditions for the efficacy evaluable population, that is subjects who received all three of the vaccinations on Study Days 0, 28, and 56; and who attended at least one subsequent study visit. Seroconversion is measured in the efficacy evaluable population.
The primary endpoint will be to determine the seroconversion rates of the vaccines. Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). A PsVNA50 titer ≥ 20 is considered positive. Sera were collected on Days 0, 28, 56, 84, 140, 168, 196, 252, 365 and evaluated for the presence of neutralizing antibodies using PsVNA50. Percentages for seroconversion are based on the number of subjects presenting non-missing data.
Outcome measures
| Measure |
Vaccine + Placebo at 1.0 mg
n=30 Participants
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 1.0 mg
n=30 Participants
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine + Placebo at 2.0 mg
n=30 Participants
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 2.0 mg
n=30 Participants
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
|---|---|---|---|---|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 28 · No Seroconversion
|
29 Participants
|
29 Participants
|
29 Participants
|
28 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 56 · Seroconversion
|
1 Participants
|
10 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 56 · No Seroconversion
|
29 Participants
|
20 Participants
|
29 Participants
|
23 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 84 · Seroconversion
|
15 Participants
|
18 Participants
|
14 Participants
|
17 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 84 · No Seroconversion
|
15 Participants
|
12 Participants
|
16 Participants
|
13 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 140 · Seroconversion
|
11 Participants
|
14 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 140 · No Seroconversion
|
19 Participants
|
14 Participants
|
20 Participants
|
16 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 168 · Seroconversion
|
12 Participants
|
11 Participants
|
7 Participants
|
13 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 168 · No Seroconversion
|
18 Participants
|
16 Participants
|
22 Participants
|
13 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 196 · Seroconversion
|
18 Participants
|
23 Participants
|
20 Participants
|
19 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 196 · No Seroconversion
|
12 Participants
|
3 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 252 · Seroconversion
|
12 Participants
|
16 Participants
|
19 Participants
|
16 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 252 · No Seroconversion
|
17 Participants
|
10 Participants
|
10 Participants
|
11 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 365 · Seroconversion
|
12 Participants
|
15 Participants
|
16 Participants
|
14 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 365 · No Seroconversion
|
8 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50
Seroconversion at Day 28 · Seroconversion
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: The time of each injection through 14 days following the procedureThe nature, frequency, and severity of solicited adverse events (AE) occurring from the time of each injection through 14 days following the procedure. The total number of events counts all solicited adverse events for all subjects. Subjects may have more than one solicited adverse event per body system and preferred term.
Outcome measures
| Measure |
Vaccine + Placebo at 1.0 mg
n=31 Participants
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 1.0 mg
n=33 Participants
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine + Placebo at 2.0 mg
n=33 Participants
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 2.0 mg
n=33 Participants
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
|---|---|---|---|---|
|
Number of Solicited Adverse Events (AEs) in Study Subjects
Total Number of Events
|
144 Adverse Events
|
148 Adverse Events
|
173 Adverse Events
|
182 Adverse Events
|
|
Number of Solicited Adverse Events (AEs) in Study Subjects
Mild
|
131 Adverse Events
|
136 Adverse Events
|
147 Adverse Events
|
155 Adverse Events
|
|
Number of Solicited Adverse Events (AEs) in Study Subjects
Moderate
|
13 Adverse Events
|
9 Adverse Events
|
25 Adverse Events
|
24 Adverse Events
|
|
Number of Solicited Adverse Events (AEs) in Study Subjects
Life Threatening
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
|
Number of Solicited Adverse Events (AEs) in Study Subjects
Severe
|
0 Adverse Events
|
3 Adverse Events
|
1 Adverse Events
|
3 Adverse Events
|
SECONDARY outcome
Timeframe: Study Days 0 to 365Population: Of the 130 subjects enrolled, 120 met the conditions for the efficacy evaluable population, that is subjects who received all three of the vaccinations on Study Days 0, 28, and 56; and who attended at least one subsequent study visit. Seroconversion is measured in the efficacy evaluable population.
Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). Sera were collected on Days 0, 28, 56, 84, 140, 168, 196, 252, 365 and evaluated for the presence of neutralizing antibodies by using PsVNA80. Percentages for seroconversion are based on the number of subjects presenting non-missing data.
Outcome measures
| Measure |
Vaccine + Placebo at 1.0 mg
n=30 Participants
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 1.0 mg
n=30 Participants
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine + Placebo at 2.0 mg
n=30 Participants
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 2.0 mg
n=30 Participants
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
|---|---|---|---|---|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 28 · Seroconversion
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 28 · No Seroconversion
|
30 Participants
|
29 Participants
|
30 Participants
|
28 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 56 · Seroconversion
|
0 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 56 · No Seroconversion
|
30 Participants
|
24 Participants
|
30 Participants
|
29 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 84 · Seroconversion
|
5 Participants
|
13 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 140 · Seroconversion
|
2 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 168 · No Seroconversion
|
26 Participants
|
19 Participants
|
26 Participants
|
23 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 365 · Seroconversion
|
5 Participants
|
9 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 365 · No Seroconversion
|
15 Participants
|
13 Participants
|
18 Participants
|
11 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 84 · No Seroconversion
|
25 Participants
|
17 Participants
|
22 Participants
|
21 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 140 · No Seroconversion
|
28 Participants
|
20 Participants
|
25 Participants
|
23 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 168 · Seroconversion
|
4 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 196 · Seroconversion
|
14 Participants
|
19 Participants
|
17 Participants
|
16 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 196 · No Seroconversion
|
16 Participants
|
7 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 252 · Seroconversion
|
6 Participants
|
13 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80
Seroconversion at Day 252 · No Seroconversion
|
23 Participants
|
13 Participants
|
20 Participants
|
17 Participants
|
Adverse Events
Vaccine + Placebo at 1.0 mg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Vaccine at 1.0 mg
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Vaccine + Placebo at 2.0 mg
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Vaccine at 2.0 mg
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaccine + Placebo at 1.0 mg
n=31 participants at risk
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 1.0 mg
n=33 participants at risk
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine + Placebo at 2.0 mg
n=33 participants at risk
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 2.0 mg
n=33 participants at risk
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
Other adverse events
| Measure |
Vaccine + Placebo at 1.0 mg
n=31 participants at risk
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 1.0 mg
n=33 participants at risk
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine + Placebo at 2.0 mg
n=33 participants at risk
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Placebo: 0.9% sodium chloride
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
Vaccine at 2.0 mg
n=33 participants at risk
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
HTNV/PUUV DNA vaccine: HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
TriGrid Delivery System (TDS): The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
General disorders
Axillary pain
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
General disorders
Fatigue
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
12.1%
4/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
General disorders
Injection site bruising
|
9.7%
3/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
9.1%
3/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
General disorders
Injection site erythema
|
9.7%
3/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
9.1%
3/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
18.2%
6/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
18.2%
6/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
General disorders
Injection site pain
|
93.5%
29/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
100.0%
33/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
90.9%
30/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
100.0%
33/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
General disorders
Injection site reaction
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
12.1%
4/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
12.1%
4/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
General disorders
Injection site swelling
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
General disorders
Local swelling
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Upper respiratory tract infection
|
12.9%
4/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
18.2%
6/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
21.2%
7/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
30.3%
10/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Respiratory rate increased
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
12.1%
4/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.7%
3/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
12.1%
4/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
15.2%
5/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Nervous system disorders
Headache
|
9.7%
3/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
9.1%
3/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
12.1%
4/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Blood and lymphatic system disorders
Neutrophilia
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Eye disorders
Scleral discolouration
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Eye disorders
Vision blurred
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Toothache
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
9.1%
3/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
General disorders
Asthenia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Immune system disorders
Allergy to chemicals
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Bacterial vaginosis
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Furuncle
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Gastroenteritis
|
6.5%
2/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Laryngitis
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Localised infection
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Pneumonia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Rhinitis
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Tooth infection
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Injury, poisoning and procedural complications
Concussion
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Injury, poisoning and procedural complications
Contusion
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.5%
2/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
15.2%
5/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
9.1%
3/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Blood creatinine increased
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Blood glucose decreased
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Blood pressure diastolic increased
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Blood pressure increased
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Blood urea increased
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Grip strength decreased
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Investigations
Transaminases increased
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
9.1%
3/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
9.1%
3/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Nervous system disorders
Presyncope
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Nervous system disorders
Tremor
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Vascular disorders
Hot flush
|
3.2%
1/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Vascular disorders
Hypertension
|
6.5%
2/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
6.1%
2/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/31 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
0.00%
0/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
3.0%
1/33 • Study Days 0 to 365
Solicited and unsolicited adverse events for all subjects who received at least one dose of vaccine reported
|
Additional Information
Dr. Kristin Mills, Principal Investigator
WRAIR Clinical Trials Center
Phone: 301-319- 2039
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place