Trial Outcomes & Findings for Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) (NCT NCT02193087)
NCT ID: NCT02193087
Last Updated: 2019-07-18
Results Overview
Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1002 participants
Primary outcome timeframe
Month 1
Results posted on
2019-07-18
Participant Flow
Participants took part in the study at 7 investigative sites in the United States from 22 July 2014 to 19 May 2015.
Healthy volunteers were enrolled in a 2:1:1:6 ratio into 1 of 4 study groups: 1 study group received 1 dose and 3 study groups received 2 doses.
Participant milestones
| Measure |
Group A: TDV Liquid + Placebo
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
|
Group B: TDV Liquid
TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
199
|
100
|
100
|
603
|
|
Overall Study
Received Vaccination
|
197
|
97
|
100
|
602
|
|
Overall Study
COMPLETED
|
162
|
86
|
93
|
524
|
|
Overall Study
NOT COMPLETED
|
37
|
14
|
7
|
79
|
Reasons for withdrawal
| Measure |
Group A: TDV Liquid + Placebo
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
|
Group B: TDV Liquid
TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
11
|
|
Overall Study
Lost to Follow-up
|
14
|
6
|
4
|
37
|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
3
|
1
|
19
|
|
Overall Study
Other Reason Not Specified
|
7
|
2
|
1
|
9
|
|
Overall Study
Did Not Receive Any Vaccination
|
2
|
3
|
0
|
1
|
Baseline Characteristics
Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
Baseline characteristics by cohort
| Measure |
Group A: TDV Liquid + Placebo
n=199 Participants
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
|
Group B: TDV Liquid
n=100 Participants
TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
n=100 Participants
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=603 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Total
n=1002 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 8.66 • n=99 Participants
|
30.9 years
STANDARD_DEVIATION 8.72 • n=107 Participants
|
34.1 years
STANDARD_DEVIATION 9.20 • n=206 Participants
|
31.9 years
STANDARD_DEVIATION 8.89 • n=7 Participants
|
32.1 years
STANDARD_DEVIATION 8.88 • n=31 Participants
|
|
Age, Customized
Adults (18-64 Years)
|
199 participants
n=99 Participants
|
100 participants
n=107 Participants
|
100 participants
n=206 Participants
|
603 participants
n=7 Participants
|
1002 participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
298 Participants
n=7 Participants
|
505 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
305 Participants
n=7 Participants
|
497 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
40 participants
n=99 Participants
|
22 participants
n=107 Participants
|
21 participants
n=206 Participants
|
120 participants
n=7 Participants
|
203 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
152 participants
n=99 Participants
|
75 participants
n=107 Participants
|
76 participants
n=206 Participants
|
464 participants
n=7 Participants
|
767 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
7 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
15 participants
n=7 Participants
|
28 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
3 participants
n=7 Participants
|
3 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Missing
|
9 participants
n=99 Participants
|
3 participants
n=107 Participants
|
0 participants
n=206 Participants
|
8 participants
n=7 Participants
|
20 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
8 participants
n=7 Participants
|
15 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
16 participants
n=7 Participants
|
25 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
51 participants
n=99 Participants
|
27 participants
n=107 Participants
|
26 participants
n=206 Participants
|
146 participants
n=7 Participants
|
250 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
5 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
125 participants
n=99 Participants
|
66 participants
n=107 Participants
|
69 participants
n=206 Participants
|
408 participants
n=7 Participants
|
668 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
15 participants
n=7 Participants
|
19 participants
n=31 Participants
|
|
Region of Enrollment
United States
|
199 participants
n=99 Participants
|
100 participants
n=107 Participants
|
100 participants
n=206 Participants
|
603 participants
n=7 Participants
|
1002 participants
n=31 Participants
|
|
Height
|
169.55 cm
STANDARD_DEVIATION 9.284 • n=99 Participants
|
171.13 cm
STANDARD_DEVIATION 10.466 • n=107 Participants
|
169.84 cm
STANDARD_DEVIATION 9.727 • n=206 Participants
|
170.69 cm
STANDARD_DEVIATION 9.680 • n=7 Participants
|
170.42 cm
STANDARD_DEVIATION 9.689 • n=31 Participants
|
|
Weight
|
76.95 kg
STANDARD_DEVIATION 14.362 • n=99 Participants
|
78.96 kg
STANDARD_DEVIATION 16.878 • n=107 Participants
|
75.96 kg
STANDARD_DEVIATION 16.099 • n=206 Participants
|
77.49 kg
STANDARD_DEVIATION 15.649 • n=7 Participants
|
77.37 kg
STANDARD_DEVIATION 15.569 • n=31 Participants
|
|
Body Mass Index (BMI)
|
26.71 kg/m^2
STANDARD_DEVIATION 4.180 • n=99 Participants
|
26.81 kg/m^2
STANDARD_DEVIATION 4.496 • n=107 Participants
|
26.30 kg/m^2
STANDARD_DEVIATION 5.006 • n=206 Participants
|
26.53 kg/m^2
STANDARD_DEVIATION 4.513 • n=7 Participants
|
26.57 kg/m^2
STANDARD_DEVIATION 4.494 • n=31 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included.
Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.
Outcome measures
| Measure |
Group A + Group B Combined
n=220 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=454 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined
DEN-1
|
635.04 titer
Interval 530.62 to 760.0
|
181.23 titer
Interval 159.92 to 205.37
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined
DEN-2
|
15104.68 titer
Interval 13135.48 to 17369.09
|
16072.59 titer
Interval 14583.29 to 17713.99
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined
DEN-3
|
186.32 titer
Interval 151.11 to 229.74
|
272.75 titer
Interval 235.75 to 315.57
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined
DEN-4
|
88.87 titer
Interval 72.29 to 109.25
|
65.67 titer
Interval 56.88 to 75.82
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 1 and 4Population: PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. "n" in each of the categories is the number of participants with data available at the given time-point.
Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. ANOVA model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.
Outcome measures
| Measure |
Group A + Group B Combined
n=74 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=454 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 1 DEN-1 (n=74, 454)
|
627.56 titer
Interval 458.91 to 858.18
|
181.23 titer
Interval 159.71 to 205.63
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 1 DEN-2 (n=74, 454)
|
17876.66 titer
Interval 14186.79 to 22526.23
|
16072.59 titer
Interval 14640.33 to 17644.97
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 1 DEN-3 (n=74, 454)
|
220.29 titer
Interval 154.23 to 314.64
|
272.75 titer
Interval 236.19 to 314.98
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 1 DEN-4 (n=74, 454)
|
88.25 titer
Interval 62.1 to 125.43
|
65.67 titer
Interval 56.98 to 75.68
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 4 DEN-1 (n=73, 435)
|
267.80 titer
Interval 205.46 to 349.06
|
113.43 titer
Interval 101.76 to 126.44
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 4 DEN-2 (n=73, 435)
|
4160.29 titer
Interval 3508.92 to 4932.58
|
3772.95 titer
Interval 3518.74 to 4045.53
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 4 DEN-3 (n=73, 435)
|
106.98 titer
Interval 85.08 to 134.52
|
132.73 titer
Interval 120.84 to 145.79
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 4 DEN-4 (n=73, 435)
|
31.56 titer
Interval 24.82 to 40.14
|
28.84 titer
Interval 26.13 to 31.82
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 1Population: Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1, and have no major protocol violations. Participants seropositive at Baseline are not included.
A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
Outcome measures
| Measure |
Group A + Group B Combined
n=220 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=454 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined
DEN-1
|
97.7 percentage of participants
Interval 94.8 to 99.3
|
93.6 percentage of participants
Interval 91.0 to 95.7
|
—
|
—
|
—
|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined
DEN-2
|
100.0 percentage of participants
Interval 98.3 to 100.0
|
99.6 percentage of participants
Interval 98.4 to 99.9
|
—
|
—
|
—
|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined
DEN-3
|
91.8 percentage of participants
Interval 87.4 to 95.1
|
93.4 percentage of participants
Interval 90.7 to 95.5
|
—
|
—
|
—
|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined
DEN-4
|
80.9 percentage of participants
Interval 75.1 to 85.9
|
80.0 percentage of participants
Interval 76.0 to 83.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 1 and 4Population: PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. "n" in each of the categories is the number of participants with data available at the given time-point.
A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
Outcome measures
| Measure |
Group A + Group B Combined
n=74 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=454 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 1 DEN-1 (n=74, 454)
|
97.3 percentage of participants
Interval 90.6 to 99.7
|
93.6 percentage of participants
Interval 91.0 to 95.7
|
—
|
—
|
—
|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 1 DEN-2 (n=74, 454)
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
99.6 percentage of participants
Interval 98.4 to 99.9
|
—
|
—
|
—
|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 1 DEN-3 (n=74, 454)
|
95.9 percentage of participants
Interval 88.6 to 99.2
|
93.4 percentage of participants
Interval 90.7 to 95.5
|
—
|
—
|
—
|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 1 DEN-4 (n=74, 454)
|
78.4 percentage of participants
Interval 67.3 to 87.1
|
80.0 percentage of participants
Interval 76.0 to 83.5
|
—
|
—
|
—
|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 4 DEN-1 (n=73, 435)
|
97.3 percentage of participants
Interval 90.5 to 99.7
|
98.2 percentage of participants
Interval 96.4 to 99.2
|
—
|
—
|
—
|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 4 DEN-2 (n=73, 435)
|
100.0 percentage of participants
Interval 95.0 to 100.0
|
100.0 percentage of participants
Interval 99.1 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 4 DEN-3 (n=73, 435)
|
98.6 percentage of participants
Interval 92.6 to 100.0
|
98.9 percentage of participants
Interval 97.3 to 99.6
|
—
|
—
|
—
|
|
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B
Month 4 DEN-4 (n=73, 435)
|
83.6 percentage of participants
Interval 73.0 to 91.2
|
79.3 percentage of participants
Interval 75.2 to 83.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 7 after each vaccinationPopulation: Participants from the Safety Set (SS) with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. "n" in each of the categories is the number of participants with data available for analysis.
Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.
Outcome measures
| Measure |
Group A + Group B Combined
n=191 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=95 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
n=294 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
n=99 Participants
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=583 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)
Pain (n=191, 95, 99, 583)
|
43.5 percentage of participants
|
48.4 percentage of participants
|
45.1 percentage of participants
|
51.5 percentage of participants
|
45.3 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)
Erythema (n=191, 95, 99, 582)
|
35.6 percentage of participants
|
41.1 percentage of participants
|
37.4 percentage of participants
|
51.5 percentage of participants
|
43.0 percentage of participants
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)
Swelling (n=191, 95, 99, 582)
|
11.5 percentage of participants
|
20.0 percentage of participants
|
14.3 percentage of participants
|
24.2 percentage of participants
|
21.6 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 through 14 after each vaccinationPopulation: Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.
Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.
Outcome measures
| Measure |
Group A + Group B Combined
n=191 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=95 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
n=99 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
n=584 Participants
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs)
Headache
|
40.8 percentage of participants
|
43.2 percentage of participants
|
38.4 percentage of participants
|
41.1 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs)
Asthenia
|
27.7 percentage of participants
|
23.2 percentage of participants
|
25.3 percentage of participants
|
26.9 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs)
Malaise
|
29.3 percentage of participants
|
27.4 percentage of participants
|
25.3 percentage of participants
|
25.3 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs)
Myalgia
|
30.4 percentage of participants
|
38.9 percentage of participants
|
30.3 percentage of participants
|
33.2 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs)
Fever (≥38 °C)
|
1.6 percentage of participants
|
3.2 percentage of participants
|
1.0 percentage of participants
|
1.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 7 after each vaccinationPopulation: Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. "n" in each of the categories is the number of participants with data available for analysis.
The percentage of participants with solicited local AEs at injection site of varying severity are reported. Solicited local AEs are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.
Outcome measures
| Measure |
Group A + Group B Combined
n=191 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=95 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
n=99 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
n=583 Participants
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity
Pain_Mild (n=191, 95, 99, 583)
|
34.6 percentage of participants
|
36.8 percentage of participants
|
41.4 percentage of participants
|
34.8 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity
Pain_Moderate (n=191, 95, 99, 583)
|
6.8 percentage of participants
|
8.4 percentage of participants
|
8.1 percentage of participants
|
9.3 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity
Pain_Severe (n=191, 95, 99, 583)
|
2.1 percentage of participants
|
3.2 percentage of participants
|
2.0 percentage of participants
|
1.2 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity
Erythema_Mild (n=191, 95, 99, 582)
|
18.3 percentage of participants
|
22.1 percentage of participants
|
18.2 percentage of participants
|
16.0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity
Erythema_Moderate (n=191, 95, 99, 582)
|
2.1 percentage of participants
|
9.5 percentage of participants
|
11.1 percentage of participants
|
6.4 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity
Erythema_Severe (n=191, 95, 99, 582)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.2 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity
Swelling_Mild (n=191, 95, 99, 582)
|
1.6 percentage of participants
|
5.3 percentage of participants
|
9.1 percentage of participants
|
5.0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity
Swelling_Moderate (n=191, 95, 99, 582)
|
0 percentage of participants
|
3.2 percentage of participants
|
5.1 percentage of participants
|
1.4 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity
Swelling_Severe (n=191, 95, 99, 582)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 14 after each vaccinationPopulation: Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.
The percentage of participants with solicited systemic AEs of varying severity are reported. Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.
Outcome measures
| Measure |
Group A + Group B Combined
n=191 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=95 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
n=99 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
n=584 Participants
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Headache_Mild
|
27.2 percentage of participants
|
26.3 percentage of participants
|
21.2 percentage of participants
|
23.1 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Headache_Moderate
|
8.4 percentage of participants
|
9.5 percentage of participants
|
13.1 percentage of participants
|
13.5 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Headache_Severe
|
5.2 percentage of participants
|
7.4 percentage of participants
|
4.0 percentage of participants
|
4.5 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Asthenia_Mild
|
18.8 percentage of participants
|
11.6 percentage of participants
|
13.1 percentage of participants
|
16.4 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Asthenia_Moderate
|
5.8 percentage of participants
|
10.5 percentage of participants
|
10.1 percentage of participants
|
7.9 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Asthenia_Severe
|
3.1 percentage of participants
|
1.1 percentage of participants
|
2.0 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Malaise_Mild
|
17.8 percentage of participants
|
15.8 percentage of participants
|
15.2 percentage of participants
|
14.0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Malaise_Moderate
|
7.3 percentage of participants
|
9.5 percentage of participants
|
7.1 percentage of participants
|
8.7 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Malaise_Severe
|
4.2 percentage of participants
|
2.1 percentage of participants
|
3.0 percentage of participants
|
2.6 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Myalgia_Mild
|
20.9 percentage of participants
|
23.2 percentage of participants
|
22.2 percentage of participants
|
23.5 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Myalgia_Moderate
|
7.3 percentage of participants
|
11.6 percentage of participants
|
6.1 percentage of participants
|
8.4 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Myalgia_Severe
|
2.1 percentage of participants
|
4.2 percentage of participants
|
2.0 percentage of participants
|
1.4 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Fever_38.0 - 38.4 °C
|
1.0 percentage of participants
|
2.1 percentage of participants
|
1.0 percentage of participants
|
1.0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Fever_38.5 - 38.9 °C
|
0.5 percentage of participants
|
1.1 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Fever_39.0 - 40.0 °C
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
Fever_>40 °C
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28 after each vaccinationPopulation: SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study, that occurred at least once within 28 days after either vaccination. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.
Outcome measures
| Measure |
Group A + Group B Combined
n=197 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=97 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
n=100 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
n=602 Participants
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs)
|
40.1 percentage of participants
|
47.4 percentage of participants
|
45.0 percentage of participants
|
43.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 6 Months after the last dose (9 months)Population: SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
A serious adverse event (SAE) is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Outcome measures
| Measure |
Group A + Group B Combined
n=197 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=97 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
n=100 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
n=602 Participants
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
1.0 percentage of participants
|
1.0 percentage of participants
|
0 percentage of participants
|
1.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 91, 97 and 104Population: The Safety Laboratory Sub-Set included randomly chosen participants from each treatment group for whom samples for clinical safety lab tests were collected and who received at least one vaccination dose. "n" in each of the categories is the number of participants with data available at the given time-point.
Percentage of participants with markedly abnormal standard safety laboratory values collected at any time after the first vaccination.
Outcome measures
| Measure |
Group A + Group B Combined
n=121 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=61 Participants
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group A and Group B Combined
n=64 Participants
Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
n=405 Participants
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
Alkaline Phosphatase (n=121,61,64,404)
|
0.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.2 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
Hemoglobin
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.2 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
Neutrophils (Abs.)
|
2.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.5 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
Lymphocytes (Abs.)
|
0.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.5 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
Eosinophils (Abs.)
|
0.8 percentage of participants
|
1.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
Neutrophils (%)
|
0.8 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.2 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
Lymphocytes (%)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.5 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
Eosinophils (%)
|
2.5 percentage of participants
|
1.6 percentage of participants
|
0 percentage of participants
|
0.5 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
Platelet Count
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.2 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
Prothrombin Time
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
aPTT
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.5 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
ALT(SGPT) (n=121,61,64,404)
|
3.3 percentage of participants
|
0 percentage of participants
|
3.1 percentage of participants
|
1.7 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
AST(SGOT) (n=121,61,64,404)
|
2.5 percentage of participants
|
0 percentage of participants
|
1.6 percentage of participants
|
1.5 percentage of participants
|
—
|
|
Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
BUN (n=121,61,64,404)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.2 percentage of participants
|
—
|
Adverse Events
Group A: TDV Liquid + Placebo
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Group B: TDV Liquid
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Group C: TDV Liquid
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Group D: TDV Lyophilized
Serious events: 8 serious events
Other events: 178 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: TDV Liquid + Placebo
n=197 participants at risk
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
|
Group B: TDV Liquid
n=97 participants at risk
TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
n=100 participants at risk
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=602 participants at risk
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Reproductive system and breast disorders
Cervical cyst
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.0%
1/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Infections and infestations
Hepatitis C
|
0.51%
1/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Psychiatric disorders
Major depression
|
0.51%
1/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Nervous system disorders
Temporal lobe epilepsy
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.17%
1/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
Other adverse events
| Measure |
Group A: TDV Liquid + Placebo
n=197 participants at risk
Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
|
Group B: TDV Liquid
n=97 participants at risk
TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group C: TDV Liquid
n=100 participants at risk
TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
Group D: TDV Lyophilized
n=602 participants at risk
TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
|
|---|---|---|---|---|
|
General disorders
Injection site erythema
|
5.1%
10/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
6.2%
6/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
10.0%
10/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
6.8%
41/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
General disorders
Injection site pain
|
2.5%
5/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
6.2%
6/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.0%
2/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
4.2%
25/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Nervous system disorders
Headache
|
4.1%
8/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
3.1%
3/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
3.7%
22/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
General disorders
Injection site pruritus
|
2.5%
5/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
4.1%
4/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
7.0%
7/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
3.2%
19/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
4/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
3.5%
21/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.51%
1/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.0%
2/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.00%
6/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
1/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.0%
1/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
3.0%
3/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.2%
7/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
2/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.0%
1/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.83%
5/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
General disorders
Fatigue
|
0.51%
1/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.3%
8/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
General disorders
Injection site discolouration
|
0.51%
1/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.0%
1/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
3.0%
3/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.8%
11/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.51%
1/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
3.1%
3/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.00%
6/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Infections and infestations
Gastroenteritis
|
0.51%
1/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
4.1%
4/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.83%
5/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.33%
2/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
10/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
3.1%
3/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.0%
2/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
3.8%
23/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.0%
2/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
4.1%
4/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.00%
6/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.0%
1/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.7%
10/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.51%
1/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.33%
2/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.51%
1/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.83%
5/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
4/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.8%
11/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
General disorders
Injection site swelling
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.0%
1/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.3%
8/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
3/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
3.0%
3/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.5%
9/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
4/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.0%
1/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.0%
1/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.50%
3/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
0.00%
0/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.2%
7/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.5%
3/197 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
2.1%
2/97 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.0%
1/100 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
1.3%
8/602 • Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each 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 vaccine.
|
Additional Information
Medical Director Clinical Science, Study Official
Takeda
Phone: +1-877-825-3327
Email: [email protected]
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