Trial Outcomes & Findings for A Trial of a Walter Reed Army Institute of Research (WRAIR) Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy US Adults (NCT NCT00239577)

Last Updated: 2019-02-19

Results Overview

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine

Results posted on

2019-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	Dengue Formulation 17a Group Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.	Dengue Formulation 17b Group Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Primary Phase STARTED	22	22	21	21
Primary Phase COMPLETED	17	19	18	21
Primary Phase NOT COMPLETED	5	3	3	0
Booster Phase STARTED	0	9	12	0
Booster Phase COMPLETED	0	9	12	0
Booster Phase NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dengue Formulation 17a Group Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.	Dengue Formulation 17b Group Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Primary Phase Adverse Event	0	0	1	0
Primary Phase Other	5	3	2	0

Baseline Characteristics

A Trial of a Walter Reed Army Institute of Research (WRAIR) Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy US Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dengue Formulation 17a Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.	Dengue Formulation 17b Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.	Total n=86 Participants Total of all reporting groups
Age, Continuous	35.90 Years STANDARD_DEVIATION 7.75 • n=5 Participants	32.80 Years STANDARD_DEVIATION 6.93 • n=7 Participants	33.0 Years STANDARD_DEVIATION 8.60 • n=5 Participants	35.8 Years STANDARD_DEVIATION 6.70 • n=4 Participants	34.37 Years STANDARD_DEVIATION 7.54 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	35 Participants n=21 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	11 Participants n=4 Participants	51 Participants n=21 Participants

PRIMARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine

Population: The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	8 Participants	3 Participants	4 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	7 Participants	2 Participants	4 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	6 Participants	4 Participants	5 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	0 Participants	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine

Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Abdominal pain	0 Participants	3 Participants	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Abdominal pain	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Abdominal pain	0 Participants	2 Participants	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia	5 Participants	2 Participants	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia	4 Participants	2 Participants	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	8 Participants	5 Participants	5 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	5 Participants	2 Participants	4 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	4 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	3 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Pruritus	4 Participants	2 Participants	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash	4 Participants	3 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash	4 Participants	3 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Vomiting	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Vomiting	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Vomiting	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	12 Participants	8 Participants	7 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	8 Participants	5 Participants	3 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches	5 Participants	2 Participants	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches	3 Participants	1 Participants	3 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Nausea	5 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Nausea	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Nausea	4 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Pain behind eyes	4 Participants	4 Participants	5 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Pain behind eyes	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Pain behind eyes	4 Participants	3 Participants	4 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Photophobia	3 Participants	1 Participants	4 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Photophobia	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Photophobia	3 Participants	1 Participants	3 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Pruritus	8 Participants	3 Participants	2 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Pruritus	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At 30 days (Month 7) after Dose 2 of the study vaccine

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=16 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=18 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=15 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=19 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-4	350 ED50 Interval 85.0 to 1439.0	91 ED50 Interval 27.0 to 305.0	84 ED50 Interval 24.0 to 294.0	6 ED50 Interval 4.0 to 8.0
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-1	241 ED50 Interval 81.0 to 719.0	83 ED50 Interval 25.0 to 273.0	204 ED50 Interval 69.0 to 603.0	7 ED50 Interval 4.0 to 14.0
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-2	691 ED50 Interval 407.0 to 1175.0	223 ED50 Interval 76.0 to 656.0	342 ED50 Interval 123.0 to 954.0	6 ED50 Interval 4.0 to 10.0
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-3	94 ED50 Interval 28.0 to 321.0	55 ED50 Interval 17.0 to 177.0	96 ED50 Interval 30.0 to 309.0	6 ED50 Interval 4.0 to 10.0

PRIMARY outcome

Timeframe: At 5 to 12 months post-Dose 2 of the study vaccine

Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects who completed the primary vaccination course, who had received the booster dose according to their random assignment and for whom data concerning immunogenicity outcome measures were available.

Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=6 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=7 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-1, Not primed	15 ED50 Interval 4.0 to 57.0	35 ED50 Interval 6.0 to 187.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-1, Primed	521 ED50 Interval 40.0 to 6785.0	2430 ED50 Interval 2430.0 to 2430.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-2, Not primed	33 ED50 Interval 5.0 to 203.0	30 ED50 Interval 6.0 to 158.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-2, Primed	346 ED50 Interval 0.0 to 97683203.0	673 ED50 Interval 10.0 to 46541.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-3, Not primed	7 ED50 Interval 3.0 to 20.0	12 ED50 Interval 4.0 to 38.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-3, Primed	426 ED50 Interval 0.0 to 785070000000000.0	1413 ED50 Interval 1165.0 to 1715.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-4, Not primed	29 ED50 Interval 2.0 to 521.0	23 ED50 Interval 3.0 to 168.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-4, Primed	123 ED50 Interval 0.0 to 15158843.0	766 ED50 Interval 1.0 to 959438.0	—	—

PRIMARY outcome

Timeframe: At Month 1 post-booster dose of the study vaccine

Titers for DEN 1, DEN 2, DEN 3 and DEN 4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=6 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=7 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-1, Not primed	39 ED50 Interval 7.0 to 226.0	73 ED50 Interval 19.0 to 281.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-1, Primed	672 ED50 Interval 55.0 to 8245.0	2430 ED50 Interval 2430.0 to 2430.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-2, Not primed	104 ED50 Interval 15.0 to 720.0	194 ED50 Interval 56.0 to 675.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-2, Primed	909 ED50 Interval 3.0 to 255163.0	795 ED50 Interval 734.0 to 861.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-3, Not primed	34 ED50 Interval 5.0 to 226.0	19 ED50 Interval 5.0 to 69.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-3, Primed	890 ED50 Interval 0.0 to 13080837.0	1502 ED50 Interval 645.0 to 3498.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-4, Not primed	46 ED50 Interval 4.0 to 535.0	31 ED50 Interval 4.0 to 231.0	—	—
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status DEN-4, Primed	215 ED50 Interval 99.0 to 463.0	618 ED50 Interval 0.0 to 2096791.0	—	—

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up after Dose 2 of the study vaccine

Population: The analysis was performed on the Primary Total Vaccinated Cohort, which included all vaccinated subjects (with at least one vaccine administration documented) with the symptom sheet filled in and for whom data were available.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=16 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=19 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=18 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=20 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	7 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	1 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up after Dose 2 of the study vaccine

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=16 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=19 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=18 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=20 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Nausea	1 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Pruritus	2 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash	3 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash	3 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Vomiting	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Vomiting	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Vomiting	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Abdominal pain	0 Participants	3 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Abdominal pain	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Abdominal pain	0 Participants	2 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia	1 Participants	2 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	4 Participants	4 Participants	3 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	3 Participants	2 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	1 Participants	2 Participants	1 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	1 Participants	2 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	6 Participants	5 Participants	3 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	3 Participants	4 Participants	1 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches	1 Participants	4 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Photophobia	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Photophobia	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches	1 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Nausea	1 Participants	3 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Nausea	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Pain behind eyes	1 Participants	4 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Pain behind eyes	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Pain behind eyes	0 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Photophobia	1 Participants	2 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Pruritus	2 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Pruritus	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up after each dose of the study vaccine

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	0 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	9 Participants	3 Participants	5 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	8 Participants	3 Participants	5 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	7 Participants	4 Participants	5 Participants	3 Participants

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up after each dose of the study vaccine

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Vomiting	2 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Abdominal pain	0 Participants	5 Participants	4 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Abdominal pain	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Abdominal pain	0 Participants	3 Participants	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia	6 Participants	4 Participants	3 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia	5 Participants	4 Participants	3 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	10 Participants	8 Participants	6 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	0 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	7 Participants	3 Participants	5 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	5 Participants	4 Participants	3 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	4 Participants	4 Participants	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	14 Participants	9 Participants	10 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	9 Participants	6 Participants	4 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches	6 Participants	5 Participants	4 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches	0 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches	4 Participants	3 Participants	4 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Nausea	6 Participants	4 Participants	3 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Nausea	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Nausea	5 Participants	2 Participants	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Vomiting	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Pain behind the eyes	4 Participants	7 Participants	5 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Pain behind the eyes	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Pain behind the eyes	4 Participants	5 Participants	4 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Photophobia	4 Participants	3 Participants	4 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Photophobia	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Photophobia	4 Participants	2 Participants	3 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Pruritus	9 Participants	3 Participants	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Pruritus	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Pruritus	6 Participants	2 Participants	3 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash	7 Participants	3 Participants	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash	7 Participants	3 Participants	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Vomiting	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up after any study vaccine dose

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Unsolicited Adverse Events (AEs)	15 Participants	10 Participants	15 Participants	12 Participants

SECONDARY outcome

Timeframe: During the whole primary phase of the study (from Day 0 up to Month 9)

Population: The analysis was performed on the Primary Total Vaccinated Cohort, included all vaccinated subjects (with at least one vaccine administration documented) for whom data were available.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up after each vaccine dose (Month 1 and Month 7)

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Alert Values for Safety Laboratory Determinations Platelet, Month 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Alert Values for Safety Laboratory Determinations ALT, Month 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Alert Values for Safety Laboratory Determinations ALT, Month 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Alert Values for Safety Laboratory Determinations AST, Month 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Alert Values for Safety Laboratory Determinations AST, Month 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Alert Values for Safety Laboratory Determinations HC, Month 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Alert Values for Safety Laboratory Determinations HC, Month 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Alert Values for Safety Laboratory Determinations NEU, Month 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Alert Values for Safety Laboratory Determinations NEU, Month 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Alert Values for Safety Laboratory Determinations Platelet, Month 7	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up after each vaccine dose and across doses

The abnormal findings at Dengue physical examination included: Rash, Generalized Rash, Skin Hemorrhage, Conjunctival Hemorrhage, Conjunctival Injection, Mucosal Hemorrhage, Lymphadenopathy, Generalized Lymphadenopathy, Hepatomegaly and Splenomegaly. Rash involved \< 50% of the body surface; Generalized rash involved at least 50% of the body surface. Generalized lymphadenopathy was defined as palpable lymph nodes in four or more of the following locations: cervical, axillary, inguinal or other, with right and left sides considered as separate locations.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Abnormal Findings at Dengue Physical Examination Generalized Lymphadenopathy,Dose 1	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Rash, Dose 1	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Generalized Rash, Dose 1	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Skin Hemorrhage, Dose 1	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Conjunctival Hemorrhage, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Conjunctival Injection, Dose 1	2 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Mucosal Hemorrhage, Dose 1	2 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Lymphadenopathy, Dose 1	3 Participants	3 Participants	4 Participants	3 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Hepatomegaly, Dose 1	2 Participants	3 Participants	5 Participants	2 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Splenomegaly, Dose 1	0 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Rash, Dose 2	2 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Skin Hemorrhage, Across	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Conjunctival Hemorrhage, Across	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Generalized Rash, Dose 2	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Conjunctival Injection, Across	2 Participants	1 Participants	2 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Mucosal Hemorrhage, Across	2 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Skin Hemorrhage, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Conjunctival Hemorrhage, Dose 2	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Conjunctival Injection, Dose 2	1 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Mucosal Hemorrhage, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Lymphadenopathy, Dose 2	1 Participants	3 Participants	5 Participants	3 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Generalized Lymphadenopathy,Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Hepatomegaly, Dose 2	1 Participants	0 Participants	3 Participants	3 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Splenomegaly, Dose 2	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Rash, Across	3 Participants	1 Participants	3 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Generalized Rash, Across	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Lymphadenopathy, Across	4 Participants	6 Participants	7 Participants	4 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Generalized Lymphadenopathy,Across	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Hepatomegaly, Across	2 Participants	3 Participants	6 Participants	4 Participants
Number of Subjects With Abnormal Findings at Dengue Physical Examination Splenomegaly, Across	0 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up after each vaccine dose and across doses

The number of subjects with suspected and confirmed Dengue post-vaccination.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Suspected and Confirmed Dengue Suspected dengue, Dose 1	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Suspected and Confirmed Dengue Confirmed dengue, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Suspected and Confirmed Dengue Suspected dengue, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Suspected and Confirmed Dengue Confirmed dengue, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Suspected and Confirmed Dengue Suspected dengue, Across doses	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Suspected and Confirmed Dengue Confirmed dengue, Across doses	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up after each vaccine dose

The number of subjects with measurable dengue viremia at specified timepoints. Negative = Genome equivalent (GEQ)/µL result is equal to zero; Undetermined = GEQ/µL result is below limit of detection (LOD); Positive = GEQ/µL result is ≥ LOD.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Measurable Dengue Viremia DEN-4 Missing, Across doses	5 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Positive, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Undetermined, Dose 1	2 Participants	1 Participants	2 Participants	1 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Negative, Dose 1	18 Participants	21 Participants	19 Participants	20 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Missing, Dose 1	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Positive, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Undetermined, Dose 2	1 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Negative, Dose 2	15 Participants	17 Participants	16 Participants	19 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Missing, Dose 2	6 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Positive, Across doses	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Undetermined, Across doses	3 Participants	3 Participants	3 Participants	2 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Negative, Across doses	13 Participants	16 Participants	15 Participants	18 Participants
Number of Subjects With Measurable Dengue Viremia DEN-1 Missing, Across doses	6 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Positive, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Undetermined, Dose 1	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Negative, Dose 1	18 Participants	20 Participants	19 Participants	19 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Missing, Dose 1	3 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Positive, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Undetermined, Dose 2	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Negative, Dose 2	15 Participants	17 Participants	15 Participants	18 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Missing, Dose 2	7 Participants	4 Participants	5 Participants	3 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Positive, Across doses	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Undetermined, Across doses	0 Participants	2 Participants	1 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Negative, Across doses	15 Participants	16 Participants	15 Participants	18 Participants
Number of Subjects With Measurable Dengue Viremia DEN-2 Missing, Across doses	7 Participants	4 Participants	5 Participants	3 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Positive, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Undetermined, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Negative, Dose 1	20 Participants	22 Participants	21 Participants	21 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Missing, Dose 1	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Positive, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Undetermined, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Negative, Dose 2	16 Participants	19 Participants	18 Participants	20 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Missing, Dose 2	6 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Positive, Across doses	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Negative, Dose 1	17 Participants	20 Participants	20 Participants	21 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Undetermined, Across doses	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Negative, Across doses	16 Participants	19 Participants	18 Participants	20 Participants
Number of Subjects With Measurable Dengue Viremia DEN-3 Missing, Across doses	6 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Positive, Dose 1	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Missing, Dose 1	2 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Positive, Dose 2	3 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Undetermined, Dose 1	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Undetermined, Dose 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Negative, Dose 2	13 Participants	19 Participants	18 Participants	20 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Missing, Dose 2	6 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Positive, Across doses	5 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Undetermined, Across doses	1 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Measurable Dengue Viremia DEN-4 Negative, Across doses	11 Participants	17 Participants	17 Participants	20 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up after each vaccine dose (Month 1 and Month 7)

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=22 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=21 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges NEU Below, Month 1	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges AST Below, Month 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges AST Above, Month 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges HC Below, Month 1	0 Participants	6 Participants	2 Participants	4 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges ALT Below, Month 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges ALT Above, Month 1	1 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges ALT Below, Month 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges HC Above, Month 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges HC Below, Month 7	3 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges ALT Above, Month 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges AST Below, Month 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges AST Above, Month 1	0 Participants	1 Participants	2 Participants	1 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges HC Above, Month 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges NEU Above, Month 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges NEU Below, Month 7	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges NEU Above, Month 7	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges Platelet Below, Month 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges Platelet Above, Month 1	0 Participants	1 Participants	2 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges Platelet Below, Month 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges Platelet Above, Month 7	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=20 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=20 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=18 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=19 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-1, Month 0	10 ED50 Interval 5.0 to 22.0	10 ED50 Interval 4.0 to 24.0	13 ED50 Interval 4.0 to 41.0	7 ED50 Interval 4.0 to 12.0
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-1, Month 1	51 ED50 Interval 15.0 to 179.0	20 ED50 Interval 8.0 to 50.0	127 ED50 Interval 36.0 to 450.0	7 ED50 Interval 3.0 to 14.0
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-2, Month 0	9 ED50 Interval 5.0 to 17.0	11 ED50 Interval 4.0 to 26.0	11 ED50 Interval 4.0 to 29.0	7 ED50 Interval 4.0 to 10.0
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-2, Month 1	230 ED50 Interval 84.0 to 630.0	94 ED50 Interval 34.0 to 261.0	287 ED50 Interval 95.0 to 870.0	7 ED50 Interval 4.0 to 10.0
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-3, Month 0	8 ED50 Interval 5.0 to 14.0	11 ED50 Interval 5.0 to 25.0	10 ED50 Interval 4.0 to 25.0	6 ED50 Interval 4.0 to 9.0
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-3, Month 1	41 ED50 Interval 13.0 to 124.0	22 ED50 Interval 10.0 to 51.0	43 ED50 Interval 14.0 to 135.0	6 ED50 Interval 4.0 to 10.0
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-4, Month 0	9 ED50 Interval 5.0 to 19.0	8 ED50 Interval 4.0 to 16.0	10 ED50 Interval 4.0 to 23.0	6 ED50 Interval 4.0 to 7.0
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 DEN-4, Month 1	59 ED50 Interval 16.0 to 224.0	52 ED50 Interval 16.0 to 173.0	63 ED50 Interval 17.0 to 238.0	6 ED50 Interval 5.0 to 8.0

SECONDARY outcome

Timeframe: At Months 0, 1 and 7

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Assay cut-off values were greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=20 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=20 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=18 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=19 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-1, Month 0	4 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-1, Month 1	11 Participants	9 Participants	13 Participants	1 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-1, Month 7	15 Participants	14 Participants	13 Participants	2 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-2, Month 0	4 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-2, Month 1	18 Participants	15 Participants	16 Participants	2 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-2, Month 7	16 Participants	15 Participants	15 Participants	2 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-3, Month 0	4 Participants	4 Participants	3 Participants	1 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-3, Month 1	12 Participants	12 Participants	12 Participants	1 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-3, Month 7	12 Participants	13 Participants	13 Participants	2 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-4, Month 0	4 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-4, Month 1	10 Participants	12 Participants	11 Participants	3 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype DEN-4, Month 7	13 Participants	14 Participants	11 Participants	1 Participants

SECONDARY outcome

Timeframe: At Months 1 and 7

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

The antibody titers and pre-vaccination status were determined by MN50 with a cut-off value equal to 1:10.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=16 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=16 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=15 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=16 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Antibody Titers Above the Assay Cut-off Value (Tetravalent Response) for All Dengue Serotypes Unprimed, Month 7	10 Participants	9 Participants	8 Participants	0 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value (Tetravalent Response) for All Dengue Serotypes Unprimed, Month 1	6 Participants	6 Participants	6 Participants	0 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value (Tetravalent Response) for All Dengue Serotypes Primed, Month 1	4 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects With Antibody Titers Above the Assay Cut-off Value (Tetravalent Response) for All Dengue Serotypes Primed, Month 7	2 Participants	3 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: At Months 1 and 7

Population: The analysis was performed on the Primary ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Sero-response defined as: For initially seronegative subjects (antibody titer \< 10 ED50 for neutralizing antibodies to DEN 1, DEN 2, DEN 3, DEN 4 prior to vaccination), antibody titer ≥ 10 ED50 at post-vaccination; For initially seropositive subjects (antibody titer ≥ 10 ED50 for neutralizing antibodies to DEN 1, DEN 2, DEN 3, DEN 4 prior to vaccination), antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=20 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=20 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=18 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group n=19 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Sero-response to Each DEN Type DEN-1, Month 1	10 Participants	6 Participants	10 Participants	0 Participants
Number of Subjects With Sero-response to Each DEN Type DEN-1, Month 7	14 Participants	11 Participants	10 Participants	1 Participants
Number of Subjects With Sero-response to Each DEN Type DEN-2, Month 1	16 Participants	13 Participants	14 Participants	0 Participants
Number of Subjects With Sero-response to Each DEN Type DEN-2, Month 7	14 Participants	13 Participants	13 Participants	0 Participants
Number of Subjects With Sero-response to Each DEN Type DEN-3, Month 1	11 Participants	8 Participants	10 Participants	0 Participants
Number of Subjects With Sero-response to Each DEN Type DEN-3, Month 7	11 Participants	11 Participants	11 Participants	1 Participants
Number of Subjects With Sero-response to Each DEN Type DEN-4, Month 1	9 Participants	10 Participants	9 Participants	2 Participants
Number of Subjects With Sero-response to Each DEN Type DEN-4, Month 7	12 Participants	12 Participants	9 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up after the study vaccine booster dose

Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all vaccinated subjects (with documented booster dose administration) with the symptom sheet filled in and for whom data were available.

Outcome measures

Outcome measures
Measure	Dengue Formulation 17b Group n=8 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group n=12 Participants Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Dengue Formulation 19 Group Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.	Placebo Group Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	0 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	0 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	1 Participants	2 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Participants	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	0 Participants	1 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) follow-up after the study vaccine booster dose

Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = oral fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.