Trial Outcomes & Findings for Safety and Immunogenicity With Two Different Serotype 2 Potencies of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Adults in Singapore (NCT NCT02425098)

Last Updated: 2019-08-28

Results Overview

GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by microneutralization test \[MNT\].

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

351 participants

Primary outcome timeframe

Day 15

Results posted on

2019-08-28

Participant Flow

Participants took part in the study at 3 investigative sites into Singapore from 03 June 2015 to 18 September 2017.

Healthy volunteers were enrolled and randomized in 1:1 ratio to receive single injection of either high-dose tetravalent dengue vaccine (HD-TDV) or tetravalent dengue vaccine (TDV).

Participant milestones

Participant milestones
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Overall Study STARTED	176	175
Overall Study COMPLETED	163	159
Overall Study NOT COMPLETED	13	16

Reasons for withdrawal

Reasons for withdrawal
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Overall Study Lost to Follow-up	7	7
Overall Study Withdrawal by Subject	4	8
Overall Study Pregnancy	2	0
Overall Study Reason not Specified	0	1

Baseline Characteristics

Data is reported only for participants with baseline seropositivity status.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=176 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=175 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Total n=351 Participants Total of all reporting groups
Age, Continuous	31.2 years STANDARD_DEVIATION 6.52 • n=176 Participants	30.9 years STANDARD_DEVIATION 6.74 • n=175 Participants	31.0 years STANDARD_DEVIATION 6.63 • n=351 Participants
Sex: Female, Male Female	103 Participants n=176 Participants	91 Participants n=175 Participants	194 Participants n=351 Participants
Sex: Female, Male Male	73 Participants n=176 Participants	84 Participants n=175 Participants	157 Participants n=351 Participants
Race/Ethnicity, Customized Non-Hispanic or Latino	176 Participants n=176 Participants	175 Participants n=175 Participants	351 Participants n=351 Participants
Race/Ethnicity, Customized Asian	173 Participants n=176 Participants	172 Participants n=175 Participants	345 Participants n=351 Participants
Race/Ethnicity, Customized White	1 Participants n=176 Participants	2 Participants n=175 Participants	3 Participants n=351 Participants
Race/Ethnicity, Customized Multiracial	2 Participants n=176 Participants	1 Participants n=175 Participants	3 Participants n=351 Participants
Region of Enrollment Singapore	176 Participants n=176 Participants	175 Participants n=175 Participants	351 Participants n=351 Participants
Height	164.26 cm STANDARD_DEVIATION 9.714 • n=176 Participants	164.33 cm STANDARD_DEVIATION 9.505 • n=175 Participants	164.29 cm STANDARD_DEVIATION 9.597 • n=351 Participants
Weight	66.44 kg STANDARD_DEVIATION 16.184 • n=176 Participants	64.96 kg STANDARD_DEVIATION 16.295 • n=175 Participants	65.70 kg STANDARD_DEVIATION 16.234 • n=351 Participants
Body Mass Index (BMI)	24.51 kg/m^2 STANDARD_DEVIATION 5.049 • n=176 Participants	23.86 kg/m^2 STANDARD_DEVIATION 4.681 • n=175 Participants	24.18 kg/m^2 STANDARD_DEVIATION 4.873 • n=351 Participants
Baseline Seropositivity Status Seropositive for at least one Dengue Serotype	92 Participants n=175 Participants • Data is reported only for participants with baseline seropositivity status.	95 Participants n=175 Participants • Data is reported only for participants with baseline seropositivity status.	187 Participants n=350 Participants • Data is reported only for participants with baseline seropositivity status.
Baseline Seropositivity Status Seronegative for all Dengue Serotypes	83 Participants n=175 Participants • Data is reported only for participants with baseline seropositivity status.	80 Participants n=175 Participants • Data is reported only for participants with baseline seropositivity status.	163 Participants n=350 Participants • Data is reported only for participants with baseline seropositivity status.
Baseline Seropositivity Rate for Each Serotype DENV-1	48.6 percentage of participants n=175 Participants • Participants with only seropositivity are reported.	48.6 percentage of participants n=175 Participants • Participants with only seropositivity are reported.	48.6 percentage of participants n=350 Participants • Participants with only seropositivity are reported.
Baseline Seropositivity Rate for Each Serotype DENV-2	47.4 percentage of participants n=175 Participants • Participants with only seropositivity are reported.	50.3 percentage of participants n=175 Participants • Participants with only seropositivity are reported.	48.9 percentage of participants n=350 Participants • Participants with only seropositivity are reported.
Baseline Seropositivity Rate for Each Serotype DENV-3	44.0 percentage of participants n=175 Participants • Participants with only seropositivity are reported.	46.3 percentage of participants n=175 Participants • Participants with only seropositivity are reported.	45.1 percentage of participants n=350 Participants • Participants with only seropositivity are reported.
Baseline Seropositivity Rate for Each Serotype DENV-4	41.7 percentage of participants n=175 Participants • Participants with only seropositivity are reported.	40.6 percentage of participants n=175 Participants • Participants with only seropositivity are reported.	41.1 percentage of participants n=350 Participants • Participants with only seropositivity are reported.

PRIMARY outcome

Timeframe: Day 15

Population: Per-protocol set (PPS) included all randomized participants who received study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.

GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by microneutralization test \[MNT\].

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 DENV-1	156.2 Titer Interval 98.0 to 249.1	110.2 Titer Interval 73.8 to 164.6
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 DENV-2	183.0 Titer Interval 116.7 to 287.0	117.6 Titer Interval 75.8 to 182.4
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 DENV-3	113.5 Titer Interval 74.7 to 172.6	69.0 Titer Interval 47.1 to 100.9
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 DENV-4	41.2 Titer Interval 29.7 to 57.2	33.9 Titer Interval 25.3 to 45.4

PRIMARY outcome

Timeframe: Day 30

Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.

GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 DENV-1	771.0 Titer Interval 525.1 to 1132.0	470.5 Titer Interval 324.4 to 682.4
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 DENV-2	8640.3 Titer Interval 7157.0 to 10431.0	1992.7 Titer Interval 1334.5 to 2975.5
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 DENV-3	390.6 Titer Interval 262.1 to 582.2	250.8 Titer Interval 168.9 to 372.5
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 DENV-4	110.2 Titer Interval 78.3 to 155.2	143.3 Titer Interval 107.0 to 191.8

PRIMARY outcome

Timeframe: Day 90

GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 DENV-3	266.5 Titer Interval 177.6 to 399.9	218.0 Titer Interval 148.1 to 320.8
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 DENV-4	85.6 Titer Interval 61.7 to 118.6	117.4 Titer Interval 87.2 to 158.1
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 DENV-1	376.5 Titer Interval 246.8 to 574.3	394.0 Titer Interval 265.0 to 585.9
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 DENV-2	4090.2 Titer Interval 3439.8 to 4863.6	1647.3 Titer Interval 1158.5 to 2342.4

PRIMARY outcome

Timeframe: Day 180

GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 DENV-1	379.4 Titer Interval 252.3 to 570.3	312.2 Titer Interval 212.2 to 459.2
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 DENV-2	2585.5 Titer Interval 2088.8 to 3200.3	1235.0 Titer Interval 890.7 to 1712.5
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 DENV-3	236.2 Titer Interval 162.2 to 344.0	161.0 Titer Interval 110.5 to 234.6
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 DENV-4	91.0 Titer Interval 65.7 to 125.9	92.9 Titer Interval 68.9 to 125.4

PRIMARY outcome

Timeframe: Day 365

GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 DENV-1	247.3 Titer Interval 160.9 to 380.2	264.1 Titer Interval 181.1 to 385.1
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 DENV-2	1726.0 Titer Interval 1392.6 to 2139.3	809.5 Titer Interval 576.6 to 1136.4
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 DENV-3	163.2 Titer Interval 110.0 to 242.3	132.6 Titer Interval 89.9 to 195.5
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 DENV-4	75.3 Titer Interval 53.8 to 105.4	77.0 Titer Interval 56.9 to 104.2

PRIMARY outcome

Timeframe: Day 15

Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 DENV-2	74.1 percentage of participants Interval 66.9 to 80.5	65.9 percentage of participants Interval 58.2 to 73.0
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 DENV-3	68.8 percentage of participants Interval 61.3 to 75.7	62.4 percentage of participants Interval 54.6 to 69.7
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 DENV-4	57.6 percentage of participants Interval 49.8 to 65.2	60.6 percentage of participants Interval 52.8 to 68.0
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 DENV-1	70.0 percentage of participants Interval 62.5 to 76.8	72.4 percentage of participants Interval 65.0 to 78.9

PRIMARY outcome

Timeframe: Day 30

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 DENV-1	97.1 percentage of participants Interval 93.4 to 99.1	91.3 percentage of participants Interval 86.0 to 95.0
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 DENV-2	98.8 percentage of participants Interval 95.9 to 99.9	89.5 percentage of participants Interval 84.0 to 93.7
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 DENV-3	89.0 percentage of participants Interval 83.4 to 93.3	83.7 percentage of participants Interval 77.3 to 88.9
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 DENV-4	78.0 percentage of participants Interval 71.1 to 84.0	87.2 percentage of participants Interval 81.3 to 91.8

PRIMARY outcome

Timeframe: Day 90

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 DENV-1	89.3 percentage of participants Interval 83.7 to 93.6	89.5 percentage of participants Interval 83.7 to 93.8
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 DENV-2	99.4 percentage of participants Interval 96.7 to 100.0	92.6 percentage of participants Interval 87.4 to 96.1
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 DENV-3	85.8 percentage of participants Interval 79.6 to 90.7	86.4 percentage of participants Interval 80.2 to 91.3
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 DENV-4	76.9 percentage of participants Interval 69.8 to 83.0	86.4 percentage of participants Interval 80.2 to 91.3

PRIMARY outcome

Timeframe: Day 180

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 DENV-1	93.4 percentage of participants Interval 88.5 to 96.6	89.6 percentage of participants Interval 83.8 to 93.8
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 DENV-2	98.2 percentage of participants Interval 94.8 to 99.6	92.6 percentage of participants Interval 87.5 to 96.1
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 DENV-3	88.0 percentage of participants Interval 82.0 to 92.5	82.2 percentage of participants Interval 75.5 to 87.7
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 DENV-4	78.9 percentage of participants Interval 71.9 to 84.9	84.0 percentage of participants Interval 77.5 to 89.3

PRIMARY outcome

Timeframe: Day 365

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 DENV-1	84.4 percentage of participants Interval 77.8 to 89.6	89.7 percentage of participants Interval 83.9 to 94.0
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 DENV-2	98.8 percentage of participants Interval 95.6 to 99.8	91.0 percentage of participants Interval 85.4 to 95.0
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 DENV-3	79.4 percentage of participants Interval 72.3 to 85.4	77.6 percentage of participants Interval 70.2 to 83.8
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 DENV-4	72.5 percentage of participants Interval 64.9 to 79.3	81.4 percentage of participants Interval 74.4 to 87.2

SECONDARY outcome

Timeframe: Within 7 days after Vaccination

Population: The safety set included all randomized participants who received the study vaccine. Here 'number analyzed' is the number of participants with data available for analysis. Only categories for which there was at least 1 participant are reported.

Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain \[Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)\], erythema \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\] and swelling \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\].

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=176 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=175 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Pain, Any Severity	81 Participants	91 Participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Pain, Grade 1	77 Participants	84 Participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Pain, Grade 2	3 Participants	6 Participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Pain, Grade 3	1 Participants	1 Participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Erythema, Any Severity	19 Participants	27 Participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Erythema, Grade 1	18 Participants	21 Participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Erythema, Grade 2	1 Participants	6 Participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Swelling, Any Severity	3 Participants	4 Participants
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Swelling, Grade 1	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Within 14 days after Vaccination

Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, asthenia, malaise and myalgia. Severity grades were: Grade 0: none, Grade 1: mild (no interference with daily activity), Grade 2: moderate (interference with daily activity with or without treatment), Grade 3: severe (prevents normal daily activity with or without treatment). A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination.

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=176 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=175 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Myalgia, Any Severity	47 Participants	47 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Myalgia, Grade 1	38 Participants	33 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Headache, Any Severity	50 Participants	61 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Headache, Grade 1	33 Participants	40 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Headache, Grade 2	14 Participants	18 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Headache, Grade 3	3 Participants	3 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Myalgia, Grade 2	7 Participants	11 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Myalgia, Grade 3	2 Participants	3 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Asthenia, Any Severity	43 Participants	56 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Asthenia, Grade 1	27 Participants	38 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Asthenia, Grade 2	15 Participants	15 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Asthenia, Grade 3	1 Participants	3 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Malaise, Any Severity	41 Participants	49 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Malaise, Grade 1	26 Participants	32 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Malaise, Grade 2	12 Participants	12 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Malaise, Grade 3	3 Participants	5 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Fever, Any Severity	9 Participants	9 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Fever, 38.0-<38.5 (C)	5 Participants	3 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Fever, 38.5-<39.0 (C)	2 Participants	4 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Fever, 39.0-<39.5 (C)	1 Participants	2 Participants
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity Fever, 39.5-<40.0 (C)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 28 days after Vaccination

Population: The safety set included all randomized participants who received the study vaccine.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a study vaccine; it does not necessarily have to have a causal relationship with study vaccine administration.

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=176 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=175 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Number of Participants With at Least One Unsolicited Adverse Events (AEs) Following Vaccination	70 Participants	78 Participants

SECONDARY outcome

Timeframe: From first vaccination through end of study (Day 365)

Population: The safety set included all randomized participants who received the study vaccine.

A serious adverse event (SAE) is 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

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=176 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=175 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Number of Participants With Serious Adverse Events (SAEs)	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Days 15, 30, 90, 180 and 365

Baseline dengue seropositivity was based on the microneutralization test (MNT) result and was defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. The four DENV serotypes are DENV-1, DENV-2, DENV-3, and DENV-4.

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-1 (Seropositive)	1256.2 Titer Interval 734.1 to 2149.4	675.2 Titer Interval 441.2 to 1033.4
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-2 (Seropositive)	1603.0 Titer Interval 1019.3 to 2521.1	1057.4 Titer Interval 699.4 to 1598.9
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-3 (Seropositive)	677.7 Titer Interval 417.1 to 1101.0	376.0 Titer Interval 245.1 to 576.8
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-4 (Seropositive)	181.8 Titer Interval 124.2 to 266.1	110.6 Titer Interval 78.8 to 155.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-3 (Seronegative)	14.5 Titer Interval 10.3 to 20.4	8.9 Titer Interval 7.0 to 11.3
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-4 (Seronegative)	7.5 Titer Interval 6.1 to 9.1	8.1 Titer Interval 6.3 to 10.4
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-1 (Seropositive)	4058.9 Titer Interval 2651.9 to 6212.2	1763.7 Titer Interval 1168.7 to 2661.6
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-2 (Seropositive)	6970.3 Titer Interval 5324.8 to 9124.3	4193.3 Titer Interval 3109.2 to 5655.5
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-3 (Seropositive)	1940.7 Titer Interval 1242.3 to 3031.6	1015.7 Titer Interval 651.9 to 1582.7
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-4 (Seropositive)	492.8 Titer Interval 342.8 to 708.5	304.7 Titer Interval 221.0 to 420.2
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-1 (Seronegative)	122.0 Titer Interval 84.9 to 175.4	95.7 Titer Interval 61.0 to 150.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-2 (Seronegative)	10965.9 Titer Interval 8472.9 to 14192.5	812.9 Titer Interval 376.0 to 1757.3
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-3 (Seronegative)	65.9 Titer Interval 42.9 to 101.4	46.5 Titer Interval 29.0 to 74.6
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-4 (Seronegative)	20.9 Titer Interval 14.9 to 29.3	57.7 Titer Interval 37.1 to 89.7
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-1 (Seropositive)	2486.8 Titer Interval 1594.1 to 3879.3	1714.5 Titer Interval 1145.9 to 2565.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-1 (Seronegative)	46.1 Titer Interval 31.4 to 67.7	71.6 Titer Interval 43.7 to 117.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-2 (Seronegative)	2941.4 Titer Interval 2243.1 to 3857.2	664.9 Titer Interval 360.3 to 1227.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-2 (Seropositive)	4412.0 Titer Interval 3586.6 to 5427.4	2952.0 Titer Interval 2358.2 to 3695.4
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-4 (Seropositive)	399.5 Titer Interval 291.3 to 547.9	268.3 Titer Interval 190.2 to 378.6
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-2 (Seronegative)	1394.1 Titer Interval 983.2 to 1976.6	444.3 Titer Interval 247.2 to 798.5
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-3 (Seronegative)	34.5 Titer Interval 23.4 to 50.7	29.0 Titer Interval 19.4 to 43.3
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-4 (Seronegative)	16.4 Titer Interval 12.3 to 22.0	26.8 Titer Interval 19.0 to 37.7
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-2 (Seropositive)	3316.0 Titer Interval 2623.8 to 4190.9	2177.3 Titer Interval 1613.5 to 2938.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-3 (Seropositive)	830.6 Titer Interval 551.2 to 1251.5	600.2 Titer Interval 402.3 to 895.3
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-4 (Seropositive)	346.3 Titer Interval 249.2 to 481.1	212.6 Titer Interval 152.2 to 296.9
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-1 (Seronegative)	30.7 Titer Interval 20.4 to 46.2	48.8 Titer Interval 32.1 to 74.2
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-2 (Seronegative)	838.7 Titer Interval 621.9 to 1131.1	247.6 Titer Interval 143.9 to 426.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-3 (Seronegative)	27.0 Titer Interval 17.8 to 41.1	21.7 Titer Interval 14.3 to 33.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-4 (Seronegative)	13.9 Titer Interval 10.3 to 19.0	22.9 Titer Interval 15.8 to 33.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-1 (Seronegative)	14.2 Titer Interval 10.3 to 19.4	12.3 Titer Interval 9.3 to 16.4
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-2 (Seronegative)	15.0 Titer Interval 11.1 to 20.4	8.3 Titer Interval 6.8 to 10.2
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-2 (Seropositive)	5501.1 Titer Interval 4473.6 to 6764.7	3601.4 Titer Interval 2626.0 to 4939.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-3 (Seropositive)	1582.8 Titer Interval 1061.9 to 2359.3	925.6 Titer Interval 603.3 to 1420.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-4 (Seropositive)	375.6 Titer Interval 267.7 to 526.9	303.8 Titer Interval 224.2 to 411.8
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-3 (Seronegative)	36.7 Titer Interval 24.0 to 56.1	40.7 Titer Interval 26.5 to 62.7
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-4 (Seronegative)	16.5 Titer Interval 12.3 to 22.2	39.0 Titer Interval 25.6 to 59.3
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-1 (Seropositive)	2327.2 Titer Interval 1550.4 to 3493.3	1356.2 Titer Interval 905.5 to 2031.2
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-3 (Seropositive)	1248.3 Titer Interval 879.7 to 1771.3	693.6 Titer Interval 459.6 to 1046.6
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-1 (Seronegative)	46.6 Titer Interval 32.0 to 67.9	55.7 Titer Interval 35.6 to 87.1
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-1 (Seropositive)	1633.3 Titer Interval 1055.8 to 2526.7	1081.5 Titer Interval 724.0 to 1615.6

SECONDARY outcome

Timeframe: Days 15, 30, 90, 180, and 365

Baseline dengue seropositivity was based on the MNT result and was defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. Seropositive rate was defined as a reciprocal neutralizing titer ≥ 10. Seropositivity was assessed for the four Dengue serotypes are DENV-1, DENV-2, DENV-3, and DEN-4.

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=173 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=174 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-1 (Seropositive)	93.4 percentage of participants Interval 86.2 to 97.5	98.9 percentage of participants Interval 94.2 to 100.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-2 (Seropositive)	93.4 percentage of participants Interval 86.2 to 97.5	95.7 percentage of participants Interval 89.4 to 98.8
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-3 (Seropositive)	91.2 percentage of participants Interval 83.4 to 96.1	91.4 percentage of participants Interval 83.8 to 96.2
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-4 (Seropositive)	89.0 percentage of participants Interval 80.7 to 94.6	91.4 percentage of participants Interval 83.8 to 96.2
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-1 (Seronegative)	43.0 percentage of participants Interval 31.9 to 54.7	40.3 percentage of participants Interval 29.2 to 52.1
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-2 (Seronegative)	51.9 percentage of participants Interval 40.4 to 63.3	29.9 percentage of participants Interval 20.0 to 41.4
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-4 (Seronegative)	59.8 percentage of participants Interval 48.3 to 70.4	75.6 percentage of participants Interval 64.6 to 84.7
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-1 (Seropositive)	98.9 percentage of participants Interval 93.9 to 100.0	100.0 percentage of participants Interval 95.8 to 100.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-4 (Seropositive)	95.5 percentage of participants Interval 88.9 to 98.8	98.9 percentage of participants Interval 93.8 to 100.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-1 (Seronegative)	78.8 percentage of participants Interval 68.2 to 87.1	77.3 percentage of participants Interval 66.2 to 86.2
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-4 (Seronegative)	56.3 percentage of participants Interval 44.7 to 67.3	72.0 percentage of participants Interval 60.4 to 81.8
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-1 (Seropositive)	100.0 percentage of participants Interval 95.9 to 100.0	100.0 percentage of participants Interval 95.9 to 100.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-2 (Seropositive)	100.0 percentage of participants Interval 95.9 to 100.0	100.0 percentage of participants Interval 95.9 to 100.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-3 (Seropositive)	100.0 percentage of participants Interval 95.9 to 100.0	96.6 percentage of participants Interval 90.4 to 99.3
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-1 (Seronegative)	69.7 percentage of participants Interval 58.1 to 79.8	77.5 percentage of participants Interval 66.0 to 86.5
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-2 (Seronegative)	97.4 percentage of participants Interval 90.8 to 99.7	81.7 percentage of participants Interval 70.7 to 89.9
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-3 (Seronegative)	61.8 percentage of participants Interval 50.0 to 72.8	54.9 percentage of participants Interval 42.7 to 66.8
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-4 (Seronegative)	47.4 percentage of participants Interval 35.8 to 59.2	64.8 percentage of participants Interval 52.5 to 75.8
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-2 (Seronegative)	98.8 percentage of participants Interval 93.4 to 100.0	78.2 percentage of participants Interval 67.4 to 86.8
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-3 (Seronegative)	80.5 percentage of participants Interval 70.3 to 88.4	69.2 percentage of participants Interval 57.8 to 79.2
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-2 (Seropositive)	100.0 percentage of participants Interval 95.9 to 100.0	98.9 percentage of participants Interval 93.8 to 100.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-3 (Seropositive)	100.0 percentage of participants Interval 95.9 to 100.0	97.7 percentage of participants Interval 91.9 to 99.7
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-2 (Seronegative)	98.8 percentage of participants Interval 93.2 to 100.0	85.3 percentage of participants Interval 75.3 to 92.4
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-3 (Seronegative)	43.0 percentage of participants Interval 31.9 to 54.7	27.3 percentage of participants Interval 17.7 to 38.6
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 15, DENV-4 (Seronegative)	21.5 percentage of participants Interval 13.1 to 32.2	23.4 percentage of participants Interval 14.5 to 34.4
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-1 (Seropositive)	100.0 percentage of participants Interval 96.0 to 100.0	100.0 percentage of participants Interval 96.2 to 100.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-2 (Seropositive)	98.9 percentage of participants Interval 94.0 to 100.0	98.9 percentage of participants Interval 94.2 to 100.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-3 (Seropositive)	96.7 percentage of participants Interval 90.7 to 99.3	95.7 percentage of participants Interval 89.5 to 98.8
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-4 (Seropositive)	94.5 percentage of participants Interval 87.6 to 98.2	96.8 percentage of participants Interval 91.0 to 99.3
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 30, DENV-1 (Seronegative)	93.9 percentage of participants Interval 86.3 to 98.0	80.8 percentage of participants Interval 70.3 to 88.8
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 90, DENV-3 (Seronegative)	70.0 percentage of participants Interval 58.7 to 79.7	73.3 percentage of participants Interval 61.9 to 82.9
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-4 (Seropositive)	95.5 percentage of participants Interval 88.9 to 98.8	96.6 percentage of participants Interval 90.4 to 99.3
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-1 (Seronegative)	85.7 percentage of participants Interval 75.9 to 92.6	77.3 percentage of participants Interval 66.2 to 86.2
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-2 (Seronegative)	96.1 percentage of participants Interval 89.0 to 99.2	84.0 percentage of participants Interval 73.7 to 91.4
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-3 (Seronegative)	74.0 percentage of participants Interval 62.8 to 83.4	65.3 percentage of participants Interval 53.5 to 76.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 180, DENV-4 (Seronegative)	59.7 percentage of participants Interval 47.9 to 70.8	69.3 percentage of participants Interval 57.6 to 79.5
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-1 (Seropositive)	97.6 percentage of participants Interval 91.7 to 99.7	100.0 percentage of participants Interval 95.8 to 100.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-2 (Seropositive)	100.0 percentage of participants Interval 95.7 to 100.0	98.8 percentage of participants Interval 93.6 to 100.0
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-3 (Seropositive)	95.2 percentage of participants Interval 88.3 to 98.7	96.5 percentage of participants Interval 90.0 to 99.3
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status Day 365, DENV-4 (Seropositive)	95.2 percentage of participants Interval 88.3 to 98.7	95.3 percentage of participants Interval 88.4 to 98.7

SECONDARY outcome

Timeframe: Days 5, 7, 9, 11, 15, 17, 21 and 30

Population: Participants from the safety analysis set, all randomized participants who received at least 1 dose of study vaccine, with data available at the given time-point.

Vaccine Viremia was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay.

Outcome measures

SECONDARY outcome

Timeframe: Days 5, 7, 9, 11, 15, 17, 21 and 30

Population: Participants from the safety analysis set, all randomized participants who received at least 1 dose of study vaccine. Here 'number analyzed' refers to participants with a positive vaccine viremia test result.

The duration of vaccine viremia for each vaccine strain was defined as the date when vaccine viremia was last detected (positive result) to date when vaccine viremia was first detected (positive result) + 1 day. It was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay.

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=176 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=175 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination TDV-4	—	1.0 days Interval 1.0 to 1.0
Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination TDV-2	5.0 days Interval 1.0 to 8.0	4.0 days Interval 1.0 to 10.0
Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination TDV-3	1.0 days Interval 1.0 to 1.0	1.0 days Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Days 5, 7, 9, 11, 15, 17, 21 and 30

Outcome measures

Outcome measures
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=176 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=175 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 7, TDV-2	3.73 log10 [genome equivalents per mL] Standard Deviation 0.631	3.78 log10 [genome equivalents per mL] Standard Deviation 0.446
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 7, TDV-3	2.82 log10 [genome equivalents per mL] Standard Deviation NA Standard Deviation (SD) was not calculated for 1 participant.	—
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 9, TDV-2	3.63 log10 [genome equivalents per mL] Standard Deviation 0.494	3.63 log10 [genome equivalents per mL] Standard Deviation 0.711
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 9, TDV-3	2.71 log10 [genome equivalents per mL] Standard Deviation NA SD was not calculated for 1 participant.	2.67 log10 [genome equivalents per mL] Standard Deviation 0.019
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 11, TDV-2	3.64 log10 [genome equivalents per mL] Standard Deviation 0.458	3.66 log10 [genome equivalents per mL] Standard Deviation 0.481
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 11, TDV-3	—	2.89 log10 [genome equivalents per mL] Standard Deviation NA SD was not calculated for 1 participant.
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 15, TDV-2	3.60 log10 [genome equivalents per mL] Standard Deviation 0.320	3.54 log10 [genome equivalents per mL] Standard Deviation 0.348
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 15, TDV-3	2.81 log10 [genome equivalents per mL] Standard Deviation NA SD was not calculated for 1 participant.	—
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 15, TDV-4	—	3.76 log10 [genome equivalents per mL] Standard Deviation NA SD was not calculated for 1 participant.
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 17, TDV-2	3.53 log10 [genome equivalents per mL] Standard Deviation 0.336	3.44 log10 [genome equivalents per mL] Standard Deviation 0.332
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 21, TDV-2	3.57 log10 [genome equivalents per mL] Standard Deviation NA SD was not calculated for 1 participant.	3.41 log10 [genome equivalents per mL] Standard Deviation 0.426
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 30, TDV-2	—	3.22 log10 [genome equivalents per mL] Standard Deviation NA SD was not calculated for 1 participant.

Adverse Events

High-dose Tetravalent Dengue Vaccine (HD-TDV)

Serious events: 3 serious events

Other events: 45 other events

Deaths: 0 deaths

Tetravalent Dengue Vaccine (TDV)

Serious events: 3 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=176 participants at risk High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=175 participants at risk Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Eye disorders Retinal tear	0.00% 0/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	0.57% 1/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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% 0/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	0.57% 1/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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 Urinary tract infection	0.57% 1/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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% 0/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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 Barotrauma	0.00% 0/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	0.57% 1/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.
Metabolism and nutrition disorders Hypokalaemia	0.57% 1/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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% 0/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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 Polyarthritis	0.57% 1/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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% 0/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.
Renal and urinary disorders Renal impairment	0.57% 1/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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% 0/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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 Endometriosis	0.00% 0/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	0.57% 1/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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

Other adverse events
Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=176 participants at risk High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=175 participants at risk Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Gastrointestinal disorders Diarrhoea	3.4% 6/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	4.0% 7/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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	2.3% 4/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	2.3% 4/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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	3.4% 6/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	3.4% 6/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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 Vessel puncture site bruise	2.3% 4/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	4.6% 8/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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 Influenza	2.3% 4/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	2.3% 4/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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	1.1% 2/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	3.4% 6/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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	2.3% 4/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	1.1% 2/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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	6.2% 11/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	4.6% 8/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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	5.1% 9/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	4.6% 8/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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 Rhinorrhoea	2.8% 5/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	5.7% 10/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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 Rash maculo-papular	2.3% 4/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	0.57% 1/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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 Rash papular	2.3% 4/176 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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.	0.57% 1/175 • Unsolicited AEs: Within 28 days after Vaccination; SAEs: From first vaccination through end of study (Day 365) At each visit the investigator documented any occurrence of adverse events 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

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

Measure	High-dose Tetravalent Dengue Vaccine (HD-TDV) n=176 Participants High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^4 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.	Tetravalent Dengue Vaccine (TDV) n=175 Participants Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\10\^4 plaque forming units (PFU), 5\10\^3 PFU, 1\10\^5 PFU, and 3\10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively.
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 15, TDV-1	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 15, TDV-2	35.5 percentage of participants Interval 28.3 to 43.1	14.6 percentage of participants Interval 9.7 to 20.8
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 5, TDV-1	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 5, TDV-2	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 5, TDV-3	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 5, TDV-4	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 9, TDV-2	44.6 percentage of participants Interval 37.0 to 52.5	13.4 percentage of participants Interval 8.7 to 19.4
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 11, TDV-3	0 percentage of participants Interval 0.0 to 2.1	0.6 percentage of participants Interval 0.0 to 3.2
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 11, TDV-4	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 21, TDV-1	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 21, TDV-2	0.6 percentage of participants Interval 0.0 to 3.1	1.7 percentage of participants Interval 0.4 to 5.0
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 21, TDV-3	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 21, TDV-4	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 7, TDV-1	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 7, TDV-2	16.6 percentage of participants Interval 11.4 to 22.9	3.4 percentage of participants Interval 1.3 to 7.4
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 7, TDV-3	0.6 percentage of participants Interval 0.0 to 3.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 7, TDV-4	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 9, TDV-1	0 percentage of participants Interval 0.0 to 2.2	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 9, TDV-3	0.6 percentage of participants Interval 0.0 to 3.3	1.2 percentage of participants Interval 0.1 to 4.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 9, TDV-4	0 percentage of participants Interval 0.0 to 2.2	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 11, TDV-1	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 11, TDV-2	48.0 percentage of participants Interval 40.3 to 55.7	19.8 percentage of participants Interval 14.1 to 26.5
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 15, TDV-3	0.6 percentage of participants Interval 0.0 to 3.2	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 15, TDV-4	0 percentage of participants Interval 0.0 to 2.1	0.6 percentage of participants Interval 0.0 to 3.2
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 17, TDV-1	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 17, TDV-2	15.0 percentage of participants Interval 10.1 to 21.2	11.7 percentage of participants Interval 7.3 to 17.5
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 17, TDV-3	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 17, TDV-4	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 30, TDV-1	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 30, TDV-2	0 percentage of participants Interval 0.0 to 2.1	0.6 percentage of participants Interval 0.0 to 3.2
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 30, TDV-3	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination Day 30, TDV-4	0 percentage of participants Interval 0.0 to 2.1	0 percentage of participants Interval 0.0 to 2.1