Trial Outcomes & Findings for Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults (NCT NCT03342898)
NCT ID: NCT03342898
Last Updated: 2020-10-08
Results Overview
Seroprotection was defined as reciprocal anti-YF neutralizing antibody titer ≥10. Immunological naivety to YF and DENV was defined as Baseline reciprocal neutralizing antibody titers \<10 for YF and for the 4 dengue serotypes. The 95% CI was calculated using exact Clopper-Pearson method.
COMPLETED
PHASE3
900 participants
Day 30
2020-10-08
Participant Flow
Participants took part in the study at 11 investigative sites in the United States from 28 Feb 2018 to 22 May 2019.
Healthy participants were enrolled in 1:1:1 ratio in 3 parallel groups. Participants received concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in Groups 1, 2 and 3.
Participant milestones
| Measure |
Group 1: YF-17D + Placebo/TDV/TDV
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
Group 3: TDV + YF-17D/TDV/Placebo
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Overall Study
STARTED
|
300
|
300
|
300
|
|
Overall Study
COMPLETED
|
246
|
247
|
246
|
|
Overall Study
NOT COMPLETED
|
54
|
53
|
54
|
Reasons for withdrawal
| Measure |
Group 1: YF-17D + Placebo/TDV/TDV
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
Group 3: TDV + YF-17D/TDV/Placebo
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
44
|
40
|
42
|
|
Overall Study
Withdrawal of Consent
|
5
|
9
|
11
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Reason not Specified
|
2
|
2
|
0
|
Baseline Characteristics
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
Baseline characteristics by cohort
| Measure |
Group 1: YF-17D + Placebo/TDV/TDV
n=300 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=300 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
Group 3: TDV + YF-17D/TDV/Placebo
n=300 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Total
n=900 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 12.41 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 12.91 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
41.0 years
STANDARD_DEVIATION 12.67 • n=4 Participants
|
|
Sex: Female, Male
Female
|
167 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
513 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
387 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
272 Participants
n=5 Participants
|
270 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
808 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
205 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
592 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Height
|
171.3 cm
STANDARD_DEVIATION 9.29 • n=5 Participants
|
170.1 cm
STANDARD_DEVIATION 9.05 • n=7 Participants
|
170.5 cm
STANDARD_DEVIATION 8.85 • n=5 Participants
|
170.6 cm
STANDARD_DEVIATION 9.07 • n=4 Participants
|
|
Weight
|
82.40 kg
STANDARD_DEVIATION 15.40 • n=5 Participants
|
78.52 kg
STANDARD_DEVIATION 14.65 • n=7 Participants
|
80.87 kg
STANDARD_DEVIATION 16.94 • n=5 Participants
|
80.60 kg
STANDARD_DEVIATION 15.75 • n=4 Participants
|
|
Body Mass Index (BMI)
|
28.00 kg/m^2
STANDARD_DEVIATION 4.29 • n=5 Participants
|
27.07 kg/m^2
STANDARD_DEVIATION 4.30 • n=7 Participants
|
27.66 kg/m^2
STANDARD_DEVIATION 4.49 • n=5 Participants
|
27.58 kg/m^2
STANDARD_DEVIATION 4.37 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: Yellow Fever Per-Protocol Set (YF PPS) included all participants YF and DENV-naïve at Baseline who received \>=1 dose of trial vaccine, with data available for Baseline and Day 30, and who had no major protocol violations. Overall number analyzed are participants with data available for analyses at given time point within pre-specified visit window.
Seroprotection was defined as reciprocal anti-YF neutralizing antibody titer ≥10. Immunological naivety to YF and DENV was defined as Baseline reciprocal neutralizing antibody titers \<10 for YF and for the 4 dengue serotypes. The 95% CI was calculated using exact Clopper-Pearson method.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=229 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=211 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=234 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Percentage of Participants Who Are YF and Dengue Virus (DENV)-Naive at Baseline and Are Seroprotected Against YF on Day 30 as Measured by Plaque Reduction Neutralization Test (PRNT)
|
99.1 percentage of participants
Interval 96.9 to 99.9
|
99.5 percentage of participants
Interval 97.4 to 100.0
|
9.8 percentage of participants
Interval 6.3 to 14.4
|
SECONDARY outcome
Timeframe: Pre-second and -third vaccination (Days 90 and 180, respectively); and 1 month post -first, second, and third vaccination (Days 30, 120, and 210, respectively)Population: Per-Protocol Set (PPS) included all participants YF and DENV-naïve at Baseline who received \>=1 dose of trial vaccine, with data available for Baseline and \>=1 post-Baseline immunogenicity measurement, and who had no major protocol violations.Number analyzed are participants with data available at given time point within pre-specified visit window.
GMTs of neutralizing antibodies was measured by microneutralization test 50% \[MNT50\] for each of the 4 dengue serotypes. The 4 DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=189 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=192 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=208 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, DENV-1
|
119.4 titer
Interval 93.0 to 153.4
|
6.0 titer
Interval 5.4 to 6.7
|
226.2 titer
Interval 178.7 to 286.4
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, DENV-2
|
650.8 titer
Interval 438.1 to 966.7
|
7.7 titer
Interval 6.6 to 9.0
|
5431.1 titer
Interval 3930.2 to 7505.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, DENV-3
|
70.9 titer
Interval 54.1 to 92.9
|
5.8 titer
Interval 5.2 to 6.4
|
172.0 titer
Interval 129.4 to 228.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, DENV-4
|
49.8 titer
Interval 39.3 to 63.1
|
6.1 titer
Interval 5.4 to 6.9
|
142.0 titer
Interval 108.7 to 185.4
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, DENV-1
|
95.1 titer
Interval 74.0 to 122.2
|
6.0 titer
Interval 5.5 to 6.6
|
147.5 titer
Interval 114.6 to 189.7
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, DENV-2
|
1547.2 titer
Interval 1198.1 to 1998.0
|
7.8 titer
Interval 6.6 to 9.2
|
2846.5 titer
Interval 2273.6 to 3563.7
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, DENV-3
|
70.1 titer
Interval 57.3 to 85.7
|
5.9 titer
Interval 5.3 to 6.5
|
73.1 titer
Interval 58.3 to 91.7
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, DENV-4
|
49.1 titer
Interval 41.0 to 58.8
|
5.9 titer
Interval 5.3 to 6.4
|
56.1 titer
Interval 45.0 to 70.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, DENV-1
|
182.6 titer
Interval 145.5 to 229.2
|
403.9 titer
Interval 335.3 to 486.6
|
297.1 titer
Interval 239.8 to 368.1
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, DENV-2
|
1947.7 titer
Interval 1639.9 to 2313.2
|
4691.3 titer
Interval 3688.6 to 5966.4
|
2616.1 titer
Interval 2133.1 to 3208.4
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, DENV-3
|
104.5 titer
Interval 87.9 to 124.1
|
636.4 titer
Interval 525.6 to 770.5
|
131.4 titer
Interval 110.5 to 156.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, DENV-4
|
97.7 titer
Interval 81.4 to 117.3
|
678.5 titer
Interval 568.7 to 809.4
|
111.8 titer
Interval 94.5 to 132.1
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, DENV-1
|
147.0 titer
Interval 115.8 to 186.6
|
251.4 titer
Interval 209.0 to 302.3
|
227.0 titer
Interval 177.4 to 290.4
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, DENV-2
|
1800.0 titer
Interval 1535.8 to 2109.7
|
2413.5 titer
Interval 2038.6 to 2857.3
|
1959.3 titer
Interval 1584.1 to 2423.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, DENV-3
|
75.8 titer
Interval 65.2 to 88.3
|
342.3 titer
Interval 294.6 to 397.9
|
84.9 titer
Interval 70.1 to 102.8
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, DENV-4
|
69.6 titer
Interval 59.0 to 82.3
|
358.4 titer
Interval 302.8 to 424.2
|
83.7 titer
Interval 69.9 to 100.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, DENV-1
|
138.2 titer
Interval 108.3 to 176.2
|
267.5 titer
Interval 221.5 to 323.2
|
679.9 titer
Interval 549.7 to 841.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, DENV-2
|
1688.0 titer
Interval 1431.7 to 1990.1
|
2248.0 titer
Interval 1902.3 to 2656.6
|
3798.1 titer
Interval 3139.4 to 4595.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, DENV-3
|
64.3 titer
Interval 54.3 to 76.2
|
301.8 titer
Interval 262.7 to 346.6
|
406.4 titer
Interval 345.4 to 478.1
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, DENV-4
|
56.6 titer
Interval 46.9 to 68.2
|
347.4 titer
Interval 297.5 to 405.6
|
436.5 titer
Interval 374.7 to 508.5
|
SECONDARY outcome
Timeframe: Pre-second and -third vaccination (Days 90 and 180, respectively); and 1-month post -first, -second, and -third vaccination (Days 30, 120, and 210, respectively)Population: PPS included all participants YF and DENV-naïve at Baseline who received \>=1 dose of trial vaccine, with data available for Baseline and \>=1 post-Baseline immunogenicity measurement, and who had no major protocol violations. Number analyzed are participants with data available at given time point within pre-specified visit window.
Seropositivity rate was defined as the percentage of seropositive participants as derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. Seropositivity for each dengue serotype were analyzed and was summarized as: DENV-1, DENV-2, DENV-3, and DENV-4.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=189 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=192 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=208 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, DENV-4
|
94.3 percentage of participants
Interval 89.8 to 97.2
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, DENV-3
|
96.3 percentage of participants
Interval 92.5 to 98.5
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
92.8 percentage of participants
Interval 88.4 to 95.9
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, DENV-4
|
96.8 percentage of participants
Interval 93.2 to 98.8
|
99.0 percentage of participants
Interval 96.3 to 99.9
|
96.6 percentage of participants
Interval 93.2 to 98.6
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, DENV-1
|
96.6 percentage of participants
Interval 92.7 to 98.7
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, DENV-2
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, DENV-3
|
93.2 percentage of participants
Interval 88.4 to 96.4
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, DENV-1
|
87.6 percentage of participants
Interval 81.9 to 92.0
|
6.5 percentage of participants
Interval 3.4 to 11.1
|
93.3 percentage of participants
Interval 88.8 to 96.4
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, DENV-2
|
88.1 percentage of participants
Interval 82.6 to 92.4
|
15.8 percentage of participants
Interval 10.8 to 21.8
|
95.9 percentage of participants
Interval 92.0 to 98.2
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, DENV-3
|
80.5 percentage of participants
Interval 74.1 to 86.0
|
4.3 percentage of participants
Interval 1.9 to 8.4
|
88.1 percentage of participants
Interval 82.7 to 92.3
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, DENV-4
|
78.4 percentage of participants
Interval 71.7 to 84.1
|
7.1 percentage of participants
Interval 3.8 to 11.8
|
89.6 percentage of participants
Interval 84.4 to 93.6
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, DENV-1
|
89.4 percentage of participants
Interval 84.1 to 93.4
|
8.3 percentage of participants
Interval 4.8 to 13.2
|
90.4 percentage of participants
Interval 85.5 to 94.0
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, DENV-2
|
94.2 percentage of participants
Interval 89.8 to 97.1
|
14.6 percentage of participants
Interval 9.9 to 20.4
|
97.1 percentage of participants
Interval 93.8 to 98.9
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, DENV-3
|
90.5 percentage of participants
Interval 85.4 to 94.3
|
5.7 percentage of participants
Interval 2.9 to 10.0
|
84.6 percentage of participants
Interval 79.0 to 89.2
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, DENV-4
|
89.4 percentage of participants
Interval 84.1 to 93.4
|
6.3 percentage of participants
Interval 3.3 to 10.7
|
84.6 percentage of participants
Interval 79.0 to 89.2
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, DENV-1
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
99.5 percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, DENV-2
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
98.5 percentage of participants
Interval 95.6 to 99.7
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, DENV-3
|
98.3 percentage of participants
Interval 95.1 to 99.6
|
98.9 percentage of participants
Interval 95.9 to 99.9
|
98.5 percentage of participants
Interval 95.6 to 99.7
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, DENV-4
|
97.7 percentage of participants
Interval 94.3 to 99.4
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
99.0 percentage of participants
Interval 96.4 to 99.9
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, DENV-1
|
95.8 percentage of participants
Interval 91.8 to 98.2
|
99.0 percentage of participants
Interval 96.3 to 99.9
|
97.1 percentage of participants
Interval 93.8 to 98.9
|
|
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, DENV-2
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
100.0 percentage of participants
Interval 98.1 to 100.0
|
97.6 percentage of participants
Interval 94.5 to 99.2
|
SECONDARY outcome
Timeframe: Pre-second and -third vaccination (Days 90 and 180, respectively); and 1-month post -first, second, and -third vaccination (Days 30, 120, and 210, respectively)Population: PPS included all participants YF and DENV-naïve at Baseline who received \>=1 dose of trial vaccine, with data available for Baseline and \>=1 post-Baseline immunogenicity measurement, and who had no major protocol violations. Number analyzed are participants with data available at given time point within pre-specified visit window.
Seropositivity rate was defined as the percentage of seropositive participants, as derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. Seropositivity for multiple dengue serotypes were summarized in the following categories: at least bivalent, at least trivalent and tetravalent.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=189 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=192 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=208 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, At Least Bivalent
|
90.8 percentage of participants
Interval 85.7 to 94.6
|
5.4 percentage of participants
Interval 2.6 to 9.8
|
96.9 percentage of participants
Interval 93.4 to 98.9
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, At Least Trivalent
|
81.6 percentage of participants
Interval 75.3 to 86.9
|
4.9 percentage of participants
Interval 2.3 to 9.1
|
91.7 percentage of participants
Interval 86.9 to 95.2
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 30, Tetravalent
|
65.9 percentage of participants
Interval 58.6 to 72.7
|
3.8 percentage of participants
Interval 1.5 to 7.7
|
79.3 percentage of participants
Interval 72.9 to 84.8
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, At Least Bivalent
|
94.7 percentage of participants
Interval 90.5 to 97.4
|
6.3 percentage of participants
Interval 3.3 to 10.7
|
95.7 percentage of participants
Interval 91.9 to 98.0
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, At Least Trivalent
|
98.3 percentage of participants
Interval 95.1 to 99.6
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
99.5 percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, At Least Trivalent
|
88.9 percentage of participants
Interval 83.5 to 93.0
|
5.7 percentage of participants
Interval 2.9 to 10.0
|
87.0 percentage of participants
Interval 81.7 to 91.3
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 90, Tetravalent
|
82.0 percentage of participants
Interval 75.8 to 87.2
|
5.7 percentage of participants
Interval 2.9 to 10.0
|
75.5 percentage of participants
Interval 69.1 to 81.2
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, At Least Bivalent
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
99.5 percentage of participants
Interval 97.2 to 100.0
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 120, Tetravalent
|
97.7 percentage of participants
Interval 94.3 to 99.4
|
98.9 percentage of participants
Interval 95.9 to 99.9
|
97.0 percentage of participants
Interval 93.5 to 98.9
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, At Least Bivalent
|
98.9 percentage of participants
Interval 96.2 to 99.9
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
99.0 percentage of participants
Interval 96.6 to 99.9
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, At Least Trivalent
|
98.4 percentage of participants
Interval 95.4 to 99.7
|
99.0 percentage of participants
Interval 96.3 to 99.9
|
97.6 percentage of participants
Interval 94.5 to 99.2
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 180, Tetravalent
|
91.5 percentage of participants
Interval 86.6 to 95.1
|
99.0 percentage of participants
Interval 96.3 to 99.9
|
88.0 percentage of participants
Interval 82.8 to 92.1
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, At Least Trivalent
|
96.0 percentage of participants
Interval 92.0 to 98.4
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, Tetravalent
|
89.2 percentage of participants
Interval 83.7 to 93.4
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline
Day 210, At Least Bivalent
|
98.9 percentage of participants
Interval 96.0 to 99.9
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
99.5 percentage of participants
Interval 97.1 to 100.0
|
SECONDARY outcome
Timeframe: 1-month post third vaccination (Day 210)Population: PPS included all participants YF and DENV-naïve at Baseline who received \>=1 dose of trial vaccine, with data available for Baseline and \>=1 post-Baseline immunogenicity measurement, and who had no major protocol violations. Overall number analyzed: participants with data available for analyses at given time point within pre-specified visit window.
Seroprotection was defined as reciprocal anti-YF neutralizing antibody titer ≥10.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=176 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=171 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=188 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Percentage of YF and DENV-naive Participants at Baseline Who Are Seroprotected Against YF on Day 210 as Measured by PRNT
|
98.9 percentage of participants
Interval 96.0 to 99.9
|
100.0 percentage of participants
Interval 97.9 to 100.0
|
98.4 percentage of participants
Interval 95.4 to 99.7
|
SECONDARY outcome
Timeframe: 1-month post-first vaccination (Day 30)Population: YF PPS included all participants YF and DENV-naïve at Baseline who received \>=1 dose of trial vaccine, with data available for Baseline and Day 30, and who had no major protocol violations. Overall number analyzed are participants with data available for analyses at given time point within pre-specified visit window.
Geometric mean titers of YF neutralizing antibodies was measured by plaque reduction neutralization test.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=229 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=211 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=234 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Anti-YF Neutralizing Antibodies at Day 30 in Participants YF and DENV-Naive at Baseline
|
4321.7 titer
Interval 3652.5 to 5113.6
|
4245.7 titer
Interval 3526.5 to 5111.6
|
6.0 titer
Interval 5.5 to 6.6
|
SECONDARY outcome
Timeframe: 1-month post-third vaccination (Day 210)Population: PPS included all participants YF and DENV-naïve at Baseline who received \>=1 dose of trial vaccine, with data available for Baseline and \>=1 post-Baseline immunogenicity measurement, and who had no major protocol violations. Overall number analyzed: participants with data available for analyses at given time point within pre-specified visit window.
Geometric mean titers of YF neutralizing antibodies was measured by plaque reduction neutralization test.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=176 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=171 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=188 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Anti-YF Neutralizing Antibodies at Day 210 in Participants YF and DENV-Naive at Baseline
|
1089.1 titer
Interval 888.1 to 1335.7
|
2341.6 titer
Interval 1938.2 to 2829.0
|
3078.2 titer
Interval 2452.0 to 3864.4
|
SECONDARY outcome
Timeframe: Within 7 Days of each Vaccination (day of vaccination + 6 days)Population: Safety Set included all randomized participants who received at least 1 dose of the trial vaccines. Number analyzed are participants with data available for the category. Only categories with at least one participant are reported.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Solicited local injection site AEs recorded from participant's-diary. Severity grade at injection site for pain: Grade 0 (No Pain), 1 (did not interfere with daily activity), 2 (interference with daily activity with or without treatment) and 3 (prevents daily activity with or without treatment). For erythema: grade 0 (\<25 mm), 1 (\>25-≤50 mm), 2 (\>50-≤100 mm) and 3 (\>100 mm). For swelling: grade 0 (\<25 mm), 1 (\>25-≤50 mm), 2 (\>50-≤100 mm) and 3 (\>100 mm). Percentages were rounded off for each category. For the first vaccination (Vac.) YF is given in Arm 1 (A1) and TDV is given in Arm 2 (A2). A1 = YF for Group 1, Placebo for Group 2, and YF for Group 3; A2 = Placebo for Group 1, TDV for Group 2, and TDV for Group 3.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=300 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=300 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=300 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3,Erythema:Moderate:>5-<=10(cm)
|
0 percentage of participants
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Any Local AEs, A1
|
27.3 percentage of participants
|
13.1 percentage of participants
|
16.8 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Any Local AEs, A2
|
48.9 percentage of participants
|
13.1 percentage of participants
|
44.2 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Pain: Any Severity, A1
|
24.1 percentage of participants
|
12.1 percentage of participants
|
16.5 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Pain: Any Severity, A2
|
42.2 percentage of participants
|
12.8 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Pain: Mild, A1
|
21.3 percentage of participants
|
9.0 percentage of participants
|
13.7 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Pain: Mild, A2
|
34.0 percentage of participants
|
10.0 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Pain: Moderate, A1
|
2.1 percentage of participants
|
3.1 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Pain: Moderate, A2
|
6.7 percentage of participants
|
2.4 percentage of participants
|
4.6 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Pain: Severe, A1
|
0.7 percentage of participants
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Pain: Severe, A2
|
1.4 percentage of participants
|
0.3 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Erythema: Any Severity, A1
|
3.9 percentage of participants
|
2.4 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Erythema: Any Severity, A2
|
19.5 percentage of participants
|
0.7 percentage of participants
|
19.6 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Erythema:Mild:2.5-5(cm), A1
|
3.9 percentage of participants
|
1.7 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Erythema:Mild:2.5-5(cm), A2
|
18.8 percentage of participants
|
0 percentage of participants
|
17.5 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Erythema:Moderate:>5-<=10(cm), A1
|
0 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Erythema:Moderate:>5-<=10(cm), A2
|
0.4 percentage of participants
|
0.7 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Erythema:Severe:>10(cm), A1
|
0 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Erythema:Severe:>10(cm), A2
|
0.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Erythema: Missing Severity, A2
|
0 percentage of participants
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Swelling: Any Severity, A1
|
2.1 percentage of participants
|
0.7 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1, Swelling: Any Severity, A2
|
5.3 percentage of participants
|
0.3 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Swelling:Mild:2.5-5(cm), A1
|
1.8 percentage of participants
|
0.3 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Swelling:Mild:2.5-5(cm), A2
|
4.6 percentage of participants
|
0 percentage of participants
|
4.2 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Swelling:Moderate:>5-<=10(cm), A1
|
0.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Swelling:Moderate:>5-<=10(cm), A2
|
0.4 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Swelling:Severe:>10(cm), A1
|
0 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 1,Swelling:Severe:>10(cm), A2
|
0.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2, Any Local AEs
|
35.7 percentage of participants
|
31.1 percentage of participants
|
35.9 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2, Pain: Any Severity
|
31.7 percentage of participants
|
27.8 percentage of participants
|
30.1 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2, Pain: Mild
|
27.8 percentage of participants
|
23.6 percentage of participants
|
25.8 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2, Pain: Moderate
|
2.8 percentage of participants
|
3.4 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2, Pain: Severe
|
1.2 percentage of participants
|
0.8 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2, Erythema: Any Severity
|
13.1 percentage of participants
|
12.3 percentage of participants
|
14.5 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2,Erythema:Mild:2.5-5(cm)
|
10.7 percentage of participants
|
10.7 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2,Erythema:Moderate:>5-<=10(cm)
|
2.4 percentage of participants
|
1.1 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2,Erythema:Severe:>10(cm)
|
0 percentage of participants
|
0.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2, Erythema: Missing Severity
|
0 percentage of participants
|
0 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2, Swelling: Any Severity
|
5.6 percentage of participants
|
2.7 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2,Swelling:Mild:2.5-5(cm)
|
4.8 percentage of participants
|
2.3 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 2,Swelling:Moderate:>5-<=10(cm)
|
0.8 percentage of participants
|
0.4 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3, Any Local AEs
|
10.6 percentage of participants
|
27.8 percentage of participants
|
10.4 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3, Pain: Any Severity
|
9.7 percentage of participants
|
24.9 percentage of participants
|
10.4 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3, Pain: Mild
|
7.9 percentage of participants
|
20.3 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3, Pain: Moderate
|
0.9 percentage of participants
|
4.2 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3, Pain: Severe
|
0.9 percentage of participants
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3, Erythema: Any Severity
|
0.9 percentage of participants
|
9.7 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3,Erythema:Mild:2.5-5(cm)
|
0.4 percentage of participants
|
8.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3,Erythema:Severe:>10(cm)
|
0.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3, Erythema: Missing Severity
|
0 percentage of participants
|
0.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3, Swelling: Any Severity
|
0 percentage of participants
|
4.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3,Swelling:Mild:2.5-5(cm)
|
0 percentage of participants
|
3.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity
After Vac. 3, Swelling: Missing Severity
|
0 percentage of participants
|
0.8 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Within 14 Days of each Vaccination (day of vaccination + 13 days)Population: Safety Set included all randomized participants who received at least 1 dose of the trial vaccines. Number analyzed are participants with data available for the category. Only categories with at least one participant are reported.
Solicited systemic AEs (fever, headache, asthenia, malaise, and myalgia) recorded from participant's-diary. Severity grades for headache are grade 0 (none), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents normal activity with or without treatment). Severity grades for asthenia, malaise and myalgia is grade 0 (none), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity), 3 (severe: prevents daily activity). Fever is defined as greater than or equal to 38º C or 100.4º C. Fever was excluded from the overall count as no severity grading was applied for it. Percentages were rounded off for each category.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=300 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=300 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=300 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Headache: Any Severity
|
39.9 percentage of participants
|
31.8 percentage of participants
|
33.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Malaise: Severe
|
2.1 percentage of participants
|
1.7 percentage of participants
|
4.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Any Systemic AEs
|
51.8 percentage of participants
|
43.6 percentage of participants
|
49.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Headache: Mild
|
26.0 percentage of participants
|
21.5 percentage of participants
|
22.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Headache: Moderate
|
9.3 percentage of participants
|
8.7 percentage of participants
|
8.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Headache: Severe
|
4.6 percentage of participants
|
1.7 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Asthenia: Any Severity
|
20.3 percentage of participants
|
17.6 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Asthenia: Mild
|
13.9 percentage of participants
|
10.0 percentage of participants
|
11.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Asthenia: Moderate
|
4.6 percentage of participants
|
5.5 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Asthenia: Severe
|
1.8 percentage of participants
|
2.1 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Malaise: Any Severity
|
24.5 percentage of participants
|
20.8 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Malaise: Mild
|
13.8 percentage of participants
|
12.8 percentage of participants
|
11.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Malaise: Moderate
|
8.5 percentage of participants
|
6.2 percentage of participants
|
4.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Myalgia: Any Severity
|
29.4 percentage of participants
|
23.2 percentage of participants
|
29.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Myalgia: Mild
|
19.1 percentage of participants
|
15.6 percentage of participants
|
19.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Myalgia: Moderate
|
8.5 percentage of participants
|
5.5 percentage of participants
|
7.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Myalgia: Severe
|
1.8 percentage of participants
|
2.1 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1, Fever: Any Severity
|
1.1 percentage of participants
|
1.4 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1,Fever:38.0-<38.5
|
0.4 percentage of participants
|
0.3 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1,Fever:38.5-<39.0
|
0.7 percentage of participants
|
0.3 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1,Fever:39.0-<39.5
|
0 percentage of participants
|
0.3 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1,Fever:39.5-<40.0
|
0 percentage of participants
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 1,Fever:≥41.0
|
0 percentage of participants
|
0.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Any Systemic AEs
|
31.7 percentage of participants
|
33.3 percentage of participants
|
29.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Headache: Any Severity
|
21.0 percentage of participants
|
22.7 percentage of participants
|
15.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Headache: Mild
|
11.9 percentage of participants
|
13.3 percentage of participants
|
10.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Headache: Moderate
|
7.1 percentage of participants
|
6.4 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Headache: Severe
|
2.0 percentage of participants
|
3.0 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Asthenia: Any Severity
|
11.5 percentage of participants
|
13.3 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Asthenia: Mild
|
6.7 percentage of participants
|
8.3 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Asthenia: Moderate
|
2.4 percentage of participants
|
3.8 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Asthenia: Severe
|
2.4 percentage of participants
|
1.1 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Malaise: Any Severity
|
9.9 percentage of participants
|
14.0 percentage of participants
|
9.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Malaise: Mild
|
4.4 percentage of participants
|
7.6 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Malaise: Moderate
|
4.0 percentage of participants
|
4.5 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Malaise: Severe
|
1.6 percentage of participants
|
1.9 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Myalgia: Any Severity
|
20.2 percentage of participants
|
20.8 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Myalgia: Mild
|
12.3 percentage of participants
|
14.4 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Myalgia: Moderate
|
5.2 percentage of participants
|
5.3 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Myalgia: Severe
|
2.8 percentage of participants
|
1.1 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2, Fever: Any Severity
|
1.2 percentage of participants
|
3.1 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2,Fever:38.0-<38.5
|
0.4 percentage of participants
|
1.5 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2,Fever:38.5-<39.0
|
0.4 percentage of participants
|
1.2 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2,Fever:39.0-<39.5
|
0 percentage of participants
|
0.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 2,Fever:39.5-<40.0
|
0.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Any Systemic AEs
|
22.8 percentage of participants
|
24.4 percentage of participants
|
27.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Headache: Any Severity
|
20.2 percentage of participants
|
17.2 percentage of participants
|
17.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Headache: Mild
|
13.6 percentage of participants
|
10.1 percentage of participants
|
11.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Headache: Moderate
|
4.8 percentage of participants
|
6.3 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Headache: Severe
|
1.8 percentage of participants
|
0.8 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Asthenia: Any Severity
|
7.0 percentage of participants
|
10.5 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Asthenia: Mild
|
3.9 percentage of participants
|
6.3 percentage of participants
|
7.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Asthenia: Moderate
|
2.6 percentage of participants
|
3.8 percentage of participants
|
1.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Asthenia: Severe
|
0.4 percentage of participants
|
0.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Malaise: Any Severity
|
11.4 percentage of participants
|
11.3 percentage of participants
|
13.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Malaise: Mild
|
7.9 percentage of participants
|
6.3 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Malaise: Moderate
|
2.6 percentage of participants
|
3.8 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Malaise: Severe
|
0.9 percentage of participants
|
1.3 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Myalgia: Any Severity
|
7.9 percentage of participants
|
12.6 percentage of participants
|
12.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Myalgia: Mild
|
4.8 percentage of participants
|
7.6 percentage of participants
|
7.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Myalgia: Moderate
|
2.6 percentage of participants
|
3.8 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Myalgia: Severe
|
0.4 percentage of participants
|
1.3 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3, Fever: Any Severity
|
1.3 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3,Fever:38.0-<38.5
|
0.9 percentage of participants
|
0.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3,Fever:38.5-<39.0
|
0 percentage of participants
|
0.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity
After Vaccination 3,Fever:39.0-<39.5
|
0.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Within 28 days (day of vaccination + 27 days) after each vaccinationPopulation: Safety Set included all randomized participants who received at least 1 dose of the trial vaccines. Number analyzed is the number of participants with data available for analyses at the given timepoint.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=300 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=300 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=300 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs)
After Second Vaccination
|
9.1 percentage of participants
|
8.8 percentage of participants
|
10.4 percentage of participants
|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs)
After First Vaccination
|
14.0 percentage of participants
|
11.7 percentage of participants
|
17.3 percentage of participants
|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs)
After Third Vaccination
|
4.7 percentage of participants
|
4.4 percentage of participants
|
5.4 percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) through end of study (Day 360)Population: Safety Set included all randomized participants who received at least 1 dose of the trial vaccines.
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=300 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=300 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=300 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Percentage of Participants With Medically Attended Adverse Events (MAAEs)
|
15.3 percentage of participants
|
14.3 percentage of participants
|
15.3 percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) through end of study (Day 360)Population: Safety Set included all randomized participants who received at least 1 dose of the trial vaccines.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event that may require intervention to prevent any of the above mentioned criteria and/or may expose the subject to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization.
Outcome measures
| Measure |
Group 3: TDV + YF-17D/TDV/Placebo
n=300 Participants
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
Group 1: YF-17D + Placebo/TDV/TDV
n=300 Participants
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=300 Participants
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
2.3 percentage of participants
|
4.3 percentage of participants
|
3.3 percentage of participants
|
Adverse Events
Group 1: YF-17D + Placebo/TDV/TDV
Group 2: TDV + Placebo/TDV/YF-17D
Group 3: TDV + YF-17D/TDV/Placebo
Serious adverse events
| Measure |
Group 1: YF-17D + Placebo/TDV/TDV
n=300 participants at risk
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=300 participants at risk
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
Group 3: TDV + YF-17D/TDV/Placebo
n=300 participants at risk
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.67%
2/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.67%
2/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Aesthesioneuroblast oma
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Social circumstances
Organ donor
|
0.33%
1/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Group 1: YF-17D + Placebo/TDV/TDV
n=300 participants at risk
YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose).
|
Group 2: TDV + Placebo/TDV/YF-17D
n=300 participants at risk
TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180.
|
Group 3: TDV + YF-17D/TDV/Placebo
n=300 participants at risk
TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180.
|
|---|---|---|---|
|
General disorders
Injection site bruising
|
1.3%
4/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.7%
5/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.3%
10/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site pruritus
|
1.0%
3/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.3%
7/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.7%
8/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
6/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.3%
13/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
4/300 • All-Cause Mortality and Serious Adverse Events: From first vaccination (Day 1) through end of study (Day 360); Other Adverse Events: From any vaccination (Day 1, Day 90, and Day 180) up to 28 days post vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER