Trial Outcomes & Findings for VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents (NCT NCT03110770)
NCT ID: NCT03110770
Last Updated: 2024-01-31
Results Overview
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
2428 participants
Primary outcome timeframe
7 days after each product administration
Results posted on
2024-01-31
Participant Flow
Part A targeted healthy adults only. Part B included adolescents in the study population. Part B sites had the option to enroll adolescents and adults, or choose to enroll only adults. The study was conducted at sites located in areas of confirmed or projected active transmission of Zika virus (ZIKV) infection.
Participant milestones
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
1170
|
1168
|
|
Overall Study
Received First Product Administration
|
30
|
30
|
30
|
1162
|
1161
|
|
Overall Study
Received Second Product Administration
|
30
|
29
|
29
|
1126
|
1127
|
|
Overall Study
Received Third Product Administration
|
29
|
27
|
28
|
1107
|
1107
|
|
Overall Study
COMPLETED
|
24
|
30
|
28
|
1037
|
1045
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
2
|
133
|
123
|
Reasons for withdrawal
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Enrolled but did not receive product
|
0
|
0
|
0
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
53
|
45
|
|
Overall Study
Investigator Decision
|
0
|
0
|
0
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
24
|
24
|
|
Overall Study
Moved from area
|
5
|
0
|
2
|
42
|
43
|
|
Overall Study
Illness/Injury unrelated to product
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents
Baseline characteristics by cohort
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=30 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1170 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
n=1168 Participants
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
Total
n=2428 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
15-17 years
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
NA Participants
n=8 Participants
|
|
Age, Customized
18-20 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
223 Participants
n=4 Participants
|
222 Participants
n=21 Participants
|
447 Participants
n=8 Participants
|
|
Age, Customized
21-30 years
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
740 Participants
n=4 Participants
|
734 Participants
n=21 Participants
|
1539 Participants
n=8 Participants
|
|
Age, Customized
31-35 years
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
195 Participants
n=21 Participants
|
408 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
595 Participants
n=4 Participants
|
601 Participants
n=21 Participants
|
1245 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
575 Participants
n=4 Participants
|
567 Participants
n=21 Participants
|
1183 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
1150 Participants
n=4 Participants
|
1139 Participants
n=21 Participants
|
2339 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
82 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
101 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
278 Participants
n=21 Participants
|
593 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
834 Participants
n=4 Participants
|
837 Participants
n=21 Participants
|
1683 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Weight
|
86.31 kilograms
STANDARD_DEVIATION 28.22 • n=5 Participants
|
79.57 kilograms
STANDARD_DEVIATION 19.84 • n=7 Participants
|
78.55 kilograms
STANDARD_DEVIATION 23.82 • n=5 Participants
|
70.80 kilograms
STANDARD_DEVIATION 16.94 • n=4 Participants
|
70.05 kilograms
STANDARD_DEVIATION 17.49 • n=21 Participants
|
70.84 kilograms
STANDARD_DEVIATION 17.65 • n=8 Participants
|
PRIMARY outcome
Timeframe: 7 days after each product administrationPopulation: All randomized participants in the study who received at least one study product administration with available data for at least one post-administration assessment for the symptom being summarized.
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=30 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1153 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
n=1148 Participants
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Pain/Tenderness · None
|
5 Participants
|
2 Participants
|
2 Participants
|
291 Participants
|
566 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Pain/Tenderness · Mild
|
21 Participants
|
21 Participants
|
14 Participants
|
600 Participants
|
482 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Swelling · None
|
26 Participants
|
25 Participants
|
23 Participants
|
1059 Participants
|
1124 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Swelling · Mild
|
4 Participants
|
5 Participants
|
6 Participants
|
82 Participants
|
22 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Swelling · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
12 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Redness · None
|
24 Participants
|
26 Participants
|
23 Participants
|
1037 Participants
|
1085 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Redness · Moderate
|
1 Participants
|
1 Participants
|
0 Participants
|
13 Participants
|
11 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Any Local Symptom · None
|
5 Participants
|
2 Participants
|
2 Participants
|
282 Participants
|
552 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Any Local Symptom · Mild
|
21 Participants
|
20 Participants
|
14 Participants
|
598 Participants
|
485 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Any Local Symptom · Moderate
|
4 Participants
|
8 Participants
|
14 Participants
|
268 Participants
|
107 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Pain/Tenderness · Moderate
|
4 Participants
|
7 Participants
|
14 Participants
|
257 Participants
|
96 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Pain/Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Redness · Mild
|
5 Participants
|
3 Participants
|
7 Participants
|
103 Participants
|
52 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Any Local Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 7 days after each product administrationPopulation: All randomized participants in the study who received at least one study product administration with available data for at least one post-administration assessment for the symptom being summarized.
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than once at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=30 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1153 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
n=1148 Participants
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Malaise · None
|
20 Participants
|
20 Participants
|
17 Participants
|
748 Participants
|
772 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Malaise · Mild
|
8 Participants
|
6 Participants
|
12 Participants
|
306 Participants
|
286 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Malaise · Moderate
|
2 Participants
|
3 Participants
|
1 Participants
|
97 Participants
|
86 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Malaise · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Myalgia · None
|
26 Participants
|
22 Participants
|
20 Participants
|
793 Participants
|
842 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Headache · None
|
20 Participants
|
15 Participants
|
17 Participants
|
696 Participants
|
713 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Nausea · Mild
|
2 Participants
|
3 Participants
|
4 Participants
|
136 Participants
|
118 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Joint Pain · Mild
|
3 Participants
|
5 Participants
|
2 Participants
|
149 Participants
|
121 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Joint Pain · Moderate
|
1 Participants
|
2 Participants
|
0 Participants
|
36 Participants
|
41 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Fever · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
22 Participants
|
24 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Any Systemic Symptom · Mild
|
10 Participants
|
12 Participants
|
19 Participants
|
421 Participants
|
394 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Any Systemic Symptom · Moderate
|
4 Participants
|
4 Participants
|
3 Participants
|
210 Participants
|
190 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Any Systemic Symptom · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
14 Participants
|
22 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Myalgia · Mild
|
3 Participants
|
6 Participants
|
8 Participants
|
270 Participants
|
227 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Myalgia · Moderate
|
1 Participants
|
2 Participants
|
2 Participants
|
86 Participants
|
77 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Headache · Mild
|
8 Participants
|
13 Participants
|
13 Participants
|
320 Participants
|
298 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Headache · Moderate
|
2 Participants
|
2 Participants
|
0 Participants
|
131 Participants
|
124 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Chills · None
|
27 Participants
|
25 Participants
|
29 Participants
|
1015 Participants
|
1029 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Chills · Mild
|
3 Participants
|
4 Participants
|
1 Participants
|
109 Participants
|
84 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Chills · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
28 Participants
|
33 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Nausea · None
|
26 Participants
|
26 Participants
|
26 Participants
|
971 Participants
|
991 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Nausea · Moderate
|
2 Participants
|
1 Participants
|
0 Participants
|
44 Participants
|
34 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Joint Pain · None
|
26 Participants
|
23 Participants
|
28 Participants
|
964 Participants
|
982 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Joint Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Fever · None
|
30 Participants
|
30 Participants
|
29 Participants
|
1090 Participants
|
1082 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Fever · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
37 Participants
|
31 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Fever · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
11 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)
Any Systemic Symptom · None
|
16 Participants
|
13 Participants
|
8 Participants
|
508 Participants
|
542 Participants
|
PRIMARY outcome
Timeframe: Day 0 after first product administration through Day 112Population: All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received.
Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included: alanine aminotransferase (ALT), white blood cells (WBC), red blood cells (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, neutrophils, lymphocytes, monocytes, eosinophils, and basophils. Laboratory safety evaluations were scheduled at baseline and weeks 4, 6, 8, 10, 12, and 16. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=30 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part A)
Eosinophil
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part A)
ALT
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part A)
WBC
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part A)
Hemoglobin
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part A)
Platelets
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part A)
Neutrophil
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part A)
Lymphocyte
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 after first product administration through Day 308Population: All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received.
Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included: alanine aminotransferase (ALT), white blood cells (WBC), red blood cells (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, neutrophils, lymphocytes, monocytes, eosinophils, and basophils. Laboratory safety evaluations were scheduled at baseline and weeks 4, 8, 16, and 44. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1162 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=1161 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part B)
ALT
|
87 Participants
|
90 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part B)
WBC
|
53 Participants
|
70 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part B)
Hemoglobin
|
49 Participants
|
53 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part B)
Platelets
|
7 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part B)
Neutrophil
|
19 Participants
|
15 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part B)
Lymphocyte
|
13 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety (Part B)
Eosinophil
|
72 Participants
|
68 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 224Population: All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received.
Any SAEs recorded from receipt of first study product administration through the last expected study visit at Day 224 are summarized. The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=30 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A)
Related to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A)
Unrelated to Study Product
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 672Population: All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received.
Any SAEs recorded from receipt of first study product administration through the last expected study visit at Day 672 are summarized. The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1162 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=1161 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B)
Related to Study Product
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B)
Unrelated to Study Product
|
17 Participants
|
18 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 224Population: All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received.
New onset chronic medical conditions were reported from receipt of first study product administration through the last expected study visit at Day 224.The relationship between a chronic medical condition and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=30 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A)
Unrelated to Study Product
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A)
Related to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 672Population: All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received.
New onset chronic medical conditions were reported from receipt of first study product administration through the last expected study visit at Day 672.The relationship between a chronic medical condition and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1162 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=1161 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B)
Related to Study Product
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B)
Unrelated to Study Product
|
15 Participants
|
9 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through the one month visit that follows the last product administration (Visit 05), 84 days for both Parts A and BPopulation: All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received.
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the one month visit that followed the last study product administration (Visit 05), 84 days for both Parts A and B for participants who received all three study product administrations. If a participant received the first and second product administrations but not the third, then the time frame was through 56 days (Visit 04). If a participant only received the first product administration but not the second or third, then the time frame was through 28 days (Visit 03). The relationship between an AE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=30 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1162 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
n=1161 Participants
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)
Related to Study Product
|
4 Participants
|
5 Participants
|
6 Participants
|
77 Participants
|
58 Participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)
Unrelated to Study Product
|
18 Participants
|
14 Participants
|
20 Participants
|
500 Participants
|
530 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 672Population: All randomized participants in the study, analyzed according to the randomized study product. One placebo participant, who had a virologically confirmed case of ZIKV from a sample collected prior to first product administration, is not counted as a virologically confirmed case.
Virologically confirmed Zika infection, irrespective of symptoms, by polymerase chain reaction (PCR) in blood or in urine were recorded from receipt of first study product administration through the last expected study visit.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1170 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=1168 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With Virologically Confirmed Cases of ZIKV (Part B Only)
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to 28 days after the third product administrationPopulation: All randomized participants, analyzed according to the randomized study product. All participants with samples at the protocol-defined immunogenicity timepoint were analyzed. The two subjects missing from Group 1 missed their Day 28 visit and thus there was no sample to analyze.
Antibody response as measured by ZIKV neutralization antibody (NAb) assay. Neutralizing activity is reported as the dilution of sera required to neutralize eighty percent of infection events (EC80).
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=28 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A)
Day 0 (Baseline, Pre-administration)
|
22.288 titer
Interval 15.056 to 32.994
|
34.836 titer
Interval 19.903 to 60.973
|
22.25 titer
Interval 14.948 to 33.121
|
—
|
—
|
|
Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A)
Day 28 After the Third Product Administration
|
77.468 titer
Interval 46.696 to 128.516
|
187.629 titer
Interval 117.826 to 298.785
|
130.497 titer
Interval 90.082 to 189.043
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to 28 days after the third product administrationPopulation: All randomized participants, analyzed according to the randomized study product. All participants with samples at the protocol-defined immunogenicity timepoint were analyzed. The two subjects missing from Group 1 missed their Day 28 visit and thus there was no sample to analyze.
A participant was a responder or met the threshold of a positive response if the post vaccination anti-ZIKV antibody titer was 30 or greater.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=28 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A)
Day 0 (Baseline, Pre-administration)
|
5 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A)
Day 28 After the Third Product Administration
|
20 Participants
|
27 Participants
|
29 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 through Day 672Population: All randomized participants in the study, analyzed according to the randomized study product. One placebo participant had a subclinical case of ZIKV from a sample collected prior to first product administration. Two placebo participants had subclinical cases of ZIKV but also reported symptomatic ZIKV cases close in time to the positive subclinical result, consistent with a clinical picture of one symptomatic ZIKV infection event for each. These 3 are not counted as subclinical cases.
Virologically confirmed cases of Zika infection without clinical signs or symptoms were recorded from receipt of first study product administration through the last expected study visit by PCR virus detection in blood of participants at regularly defined intervals. Subclinical cases of ZIKV infection were identified by retrospective PCR.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1170 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=1168 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With Subclinical Cases of ZIKV (Part B Only)
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to 28 days after the third product administrationPopulation: Subset of per protocol population, which included randomly selected study participants who received three administrations within window as assigned by the randomization schedule and did not have any other major protocol deviations prior to their Week 12 visit, was analyzed to meet statistical power.
Antibody response as measured by ZIKV neutralization antibody (NAb) assay. Neutralizing activity is reported as the dilution of sera required to neutralize fifty percent of infection events (EC50).
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=143 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=51 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B)
Day 0 (Baseline, Pre-administration)
|
94.7 titer
Interval 68.5 to 131.1
|
205.3 titer
Interval 113.0 to 373.2
|
—
|
—
|
—
|
|
Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B)
Day 28 After the Third Product Administration
|
567.7 titer
Interval 448.3 to 718.9
|
191.9 titer
Interval 108.1 to 340.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to 28 days after the third product administrationPopulation: Subset of per protocol population, which included randomly selected study participants who received three administrations within window as assigned by the randomization schedule and did not have any other major protocol deviations prior to their Week 12 visit, was analyzed to meet statistical power.
A participant is a responder or met the threshold of a positive response if the post vaccination anti-ZIKV antibody titer was 30 or greater.
Outcome measures
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=143 Participants
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=51 Participants
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B)
Day 0 (Baseline, Pre-administration)
|
80 Participants
|
35 Participants
|
—
|
—
|
—
|
|
Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B)
Day 28 After the Third Product Administration
|
139 Participants
|
35 Participants
|
—
|
—
|
—
|
Adverse Events
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
Serious events: 1 serious events
Other events: 28 other events
Deaths: 1 deaths
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
Serious events: 17 serious events
Other events: 990 other events
Deaths: 1 deaths
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
Serious events: 18 serious events
Other events: 859 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=30 participants at risk
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 participants at risk
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 participants at risk
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1162 participants at risk
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
n=1161 participants at risk
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Congenital, familial and genetic disorders
Congenital hydronephrosis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.17%
2/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.34%
4/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Influenza
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.17%
2/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Skin infection
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.17%
2/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucinous cystadenocarcinoma ovary
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Nervous system disorders
Seizure
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Psychiatric disorders
Depression
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.17%
2/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.09%
1/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
Other adverse events
| Measure |
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=30 participants at risk
Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections
n=30 participants at risk
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections
n=30 participants at risk
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections
n=1162 participants at risk
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device
VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
|
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections
n=1161 participants at risk
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device
VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
4.4%
51/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
4.8%
56/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
4.2%
49/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
5.8%
67/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.34%
4/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.26%
3/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
1.6%
19/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
1.3%
15/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Cardiac disorders
Bradycardia
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
1.8%
21/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.1%
24/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
4/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
13.3%
4/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
13.3%
4/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
15.7%
182/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
13.5%
157/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Administration site erythema
|
20.0%
6/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
13.3%
4/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
23.3%
7/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
10.0%
116/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
5.4%
63/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Administration site pain
|
83.3%
25/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
93.3%
28/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
93.3%
28/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
74.2%
862/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
50.1%
582/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Administration site swelling
|
13.3%
4/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
16.7%
5/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
23.3%
7/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
8.1%
94/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.1%
24/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Chills
|
10.0%
3/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
16.7%
5/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
12.0%
139/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
10.2%
119/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Injection site bruising
|
16.7%
5/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
33.3%
10/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
43.3%
13/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.7%
31/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.2%
26/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Injection site pruritus
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
1.0%
12/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.26%
3/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Malaise
|
33.3%
10/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
33.3%
10/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
43.3%
13/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
34.9%
405/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
32.4%
376/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.95%
11/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
1.5%
17/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Pharyngitis
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.4%
28/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
1.9%
22/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.26%
3/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.43%
5/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
4/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
16.7%
5/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.1%
36/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.0%
35/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Viral infection
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
1.8%
21/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.2%
26/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
3/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
10.0%
3/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
7.5%
87/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
7.9%
92/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
4/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
23.3%
7/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
16.3%
189/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
14.4%
167/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
4/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
26.7%
8/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
33.3%
10/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
31.2%
362/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
26.4%
306/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Nervous system disorders
Headache
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
1.8%
21/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.60%
7/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.34%
4/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.26%
3/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.7%
2/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.17%
2/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.26%
3/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Vascular disorders
Hypertension
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
10.0%
3/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.2%
26/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.3%
27/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.2%
72/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
5.9%
69/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Pyrexia
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
3.3%
1/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
5.4%
63/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
5.7%
66/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/30 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
6.2%
72/1162 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
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6.5%
75/1161 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
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Additional Information
VRC Clinical Trials Program Leadership
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301-451-8715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place