Trial Outcomes & Findings for Safety and Immunogenicity of Various Formulations of Live Attenuated Tetravalent Dengue Vaccine in Healthy US Adults (NCT NCT00350337)

Last Updated: 2021-02-12

Results Overview

GMTs for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3

Results posted on

2021-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Pre-transfection F17 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection. Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Overall Study STARTED	22	22	21	21
Overall Study COMPLETED	17	19	18	21
Overall Study NOT COMPLETED	5	3	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity of Various Formulations of Live Attenuated Tetravalent Dengue Vaccine in Healthy US Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-transfection F17 n=22 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=22 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection. Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=21 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo n=21 Participants A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	22 Participants n=7 Participants	21 Participants n=5 Participants	21 Participants n=4 Participants	86 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	35.9 years STANDARD_DEVIATION 7.75 • n=5 Participants	32.8 years STANDARD_DEVIATION 6.93 • n=7 Participants	33 years STANDARD_DEVIATION 8.6 • n=5 Participants	35.8 years STANDARD_DEVIATION 6.7 • n=4 Participants	34.3 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
Region of Enrollment United States	22 participants n=5 Participants	22 participants n=7 Participants	21 participants n=5 Participants	21 participants n=4 Participants	86 participants n=21 Participants

PRIMARY outcome

Timeframe: Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3

Population: Number of subjects with titer within specified range

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=16 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=16 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=15 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-1: PRE	2 GMT value Interval 2.0 to 2.0	2 GMT value Interval 2.0 to 2.0	2 GMT value Interval 2.0 to 2.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-1: PI(M1)	13 GMT value Interval 3.0 to 53.0	8 GMT value Interval 4.0 to 17.0	55 GMT value Interval 11.0 to 281.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-1: PII(M7)	195 GMT value Interval 57.0 to 665.0	46 GMT value Interval 12.0 to 175.0	98 GMT value Interval 25.0 to 387.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-1: PRE III	NA GMT value Data not collected for this time point	10.2 GMT value Interval 1.7 to 61.6	30.3 GMT value Interval 4.6 to 197.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-1: PIII(M1)	NA GMT value Data not collected at this time point	42.7 GMT value Interval 8.4 to 217.0	73.3 GMT value Interval 19.1 to 280.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-2: PRE	2 GMT value Interval 2.0 to 2.0	2 GMT value Interval 2.0 to 2.0	2 GMT value Interval 1.0 to 2.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-2: P1(M1)	141 GMT value Interval 43.0 to 460.0	49 GMT value Interval 14.0 to 169.0	168 GMT value Interval 41.0 to 680.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-2: PII(M7)	666 GMT value Interval 376.0 to 1179.0	125 GMT value Interval 30.0 to 523.0	226 GMT value Interval 70.0 to 729.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-2: PRE III	NA GMT value Data not collected for this time point	30 GMT value Interval 3.9 to 227.0	31.5 GMT value Interval 6.3 to 157.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-2: PIII(M1)	NA GMT value Data not collected for this time point	100 GMT value Interval 13.3 to 749.0	194.5 GMT value Interval 56.1 to 674.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-3: PRE	2 GMT value Interval 2.0 to 2.0	2 GMT value Interval 2.0 to 2.0	2 GMT value Interval 2.0 to 2.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-3: PI(M1)	13 GMT value Interval 4.0 to 38.0	9 GMT value Interval 4.0 to 18.0	16 GMT value Interval 5.0 to 50.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-3: PII(M7)	78 GMT value Interval 21.0 to 286.0	27 GMT value Interval 8.0 to 98.0	48 GMT value Interval 13.0 to 177.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-3: PRE III	NA GMT value Data not collected for this time point	4.1 GMT value Interval 1.0 to 16.9	10.1 GMT value Interval 2.5 to 40.9	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-3: PIII(M1)	NA GMT value Data not collected for this time point	28.2 GMT value Interval 3.2 to 249.4	19.7 GMT value Interval 5.6 to 69.8	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-4: PRE	2 GMT value Interval 2.0 to 2.0	2 GMT value Interval 2.0 to 2.0	2 GMT value Interval 2.0 to 2.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-4: PI(M1)	16 GMT value Interval 4.0 to 74.0	30 GMT value Interval 6.0 to 150.0	28 GMT value Interval 6.0 to 128.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-4: PII(M7)	271 GMT value Interval 53.0 to 1378.0	62 GMT value Interval 14.0 to 284.0	41 GMT value Interval 10.0 to 176.0	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-4: PRE III	NA GMT value Data not collected for this time point	17.3 GMT value Interval 0.6 to 491.9	12.1 GMT value Interval 1.0 to 1466.2	—
N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 DEN-4: PIII(M1)	NA GMT value Data not collected for this time point	44.4 GMT value Interval 3.7 to 539.2	32.2 GMT value Interval 4.5 to 232.2	—

PRIMARY outcome

Timeframe: Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3

Population: Vaccinated subjects for whom assay results were available.

Serpositivity rates for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=16 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=16 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=15 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-1: PRE	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 21.8	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-1: PI(M1)	43.8 percentage of participants Interval 19.8 to 70.1	37.5 percentage of participants Interval 15.2 to 64.6	66.7 percentage of participants Interval 38.4 to 88.2	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-1: PII(M7)	92.9 percentage of participants Interval 66.1 to 99.8	73.3 percentage of participants Interval 44.9 to 92.2	83.3 percentage of participants Interval 51.6 to 97.9	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-1: PRE III	NA percentage of participants Data not collected for this time point	66.7 percentage of participants Interval 22.3 to 95.7	71.4 percentage of participants Interval 29.0 to 96.3	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-1: PIII(M1)	NA percentage of participants Data not collected for this time point	83.3 percentage of participants Interval 35.9 to 99.6	100 percentage of participants Interval 59.0 to 100.0	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-2: PRE	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 21.8	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-2: PI(M1)	87.5 percentage of participants Interval 61.7 to 98.4	68.8 percentage of participants Interval 41.3 to 89.0	86.7 percentage of participants Interval 59.5 to 98.3	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-2: PII(M7)	100 percentage of participants Interval 76.8 to 100.0	80.0 percentage of participants Interval 51.9 to 95.7	100 percentage of participants Interval 73.5 to 100.0	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-2: PRE III	NA percentage of participants Data not collected for this time point	66.7 percentage of participants Interval 22.3 to 95.7	57.1 percentage of participants Interval 18.4 to 90.1	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-2: PIII(M1)	NA percentage of participants Data not collected for this time point	83.3 percentage of participants Interval 35.9 to 99.6	100 percentage of participants Interval 59.0 to 100.0	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-3: PRE	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 21.8	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-3: PI(M1)	50.0 percentage of participants Interval 24.7 to 75.3	50.0 percentage of participants Interval 24.7 to 75.3	60.0 percentage of participants Interval 32.3 to 83.7	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-4: PRE	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 20.6	0.0 percentage of participants Interval 0.0 to 21.8	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-4: PI(M1)	37.5 percentage of participants Interval 15.2 to 64.6	56.3 percentage of participants Interval 29.9 to 80.2	53.3 percentage of participants Interval 26.6 to 78.7	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-4: PII(M7)	78.6 percentage of participants Interval 49.2 to 95.3	73.3 percentage of participants Interval 44.9 to 92.2	66.7 percentage of participants Interval 34.9 to 90.1	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-4: PRE III	NA percentage of participants Data not collected for this time point	33.3 percentage of participants Interval 4.3 to 77.7	42.9 percentage of participants Interval 9.9 to 81.6	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-4: PIII(M1)	NA percentage of participants Data not collected for this time point	83.3 percentage of participants Interval 35.9 to 99.6	57.1 percentage of participants Interval 18.4 to 90.1	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-3: PII(M7)	71.4 percentage of participants Interval 41.9 to 91.6	66.7 percentage of participants Interval 38.4 to 88.2	83.3 percentage of participants Interval 51.6 to 97.9	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-3: PRE III	NA percentage of participants Data not collected for this time point	16.7 percentage of participants Interval 0.4 to 64.1	42.9 percentage of participants Interval 9.9 to 81.6	—
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 DEN-3: PIII(M1)	NA percentage of participants Data not collected for this time point	83.3 percentage of participants Interval 35.9 to 99.6	57.1 percentage of participants Interval 18.4 to 90.1	—

PRIMARY outcome

Timeframe: 21 days following 1st vaccination dose

Diary cards, digital thermometers, and small rulers were provided to subjects to record local and general solicited symptoms(pain, redness and swelling at the injection site, fatigue, headache, pain behind the eyes, abdominal pain, nausea, vomiting, muscle aches, joint aches, rash, photophobia and pruritis) and oral temperature taken daily for 21 days (days 0 through 20). The observations were to be recorded each evening and account for the previous 24 hours. If multiple temperature measurements were taken throughout the day, the maximum temperature was to be recorded.

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=22 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=22 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=21 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo n=21 Participants A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine Any Grade 3 symptoms	1 participants	1 participants	4 participants	3 participants
Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine General Grade 3 symptoms	0 participants	0 participants	3 participants	2 participants
Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine Local Grade 3 symptoms	1 participants	1 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: within 21 days after vaccination

Population: Subjects with sufficient data to perform safety analysis

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=16 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=19 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=18 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo n=20 Participants A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine; Any Grade 3 symptoms	1 participants	1 participants	1 participants	0 participants
Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine; General Grade 3 symptoms	1 participants	1 participants	1 participants	0 participants
Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine; Local Grade 3 symptoms	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: within 31 days of study vaccine

Summary of Unsolicited Adverse Events within 31 days after each dose of study vaccine dose (Primary total vaccinated cohort)

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=22 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=22 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=21 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo n=21 Participants A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose Any symptoms classified by MedDRA	27 Number of AEs	17 Number of AEs	24 Number of AEs	30 Number of AEs
Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose Any symptoms reported	27 Number of AEs	17 Number of AEs	24 Number of AEs	31 Number of AEs
Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose Grade 3 symptoms classified by MedDRA	1 Number of AEs	2 Number of AEs	3 Number of AEs	2 Number of AEs
Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose Grade 3 and casually related symptoms reported	0 Number of AEs	0 Number of AEs	0 Number of AEs	1 Number of AEs
Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose Grade 3 symptoms reported	1 Number of AEs	2 Number of AEs	3 Number of AEs	2 Number of AEs
Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose Casually related symptoms classified by MedDRA	6 Number of AEs	1 Number of AEs	3 Number of AEs	6 Number of AEs
Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose Casually related symptoms reported	6 Number of AEs	1 Number of AEs	3 Number of AEs	7 Number of AEs

SECONDARY outcome

Timeframe: Days 0 to 270

Serious adverse events will be recorded throughout the entire study period. Subjects instructed to contact the investigator immediately should they manifest any signs or symptoms they perceive as serious. An identification card and a set of phone numbers to contact study staff 24 hours a day, 7 days a week given to subjects.

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=22 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=22 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=21 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo n=21 Participants A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Occurrence of Serious Adverse Events (SAEs) Throughout the Entire Study Period.	0 participants	2 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: throughout the 202 day study

Abnormal findings at DEN physical examination were defined as: rash, generalized rash, hemorrhages (skin, conjunctival or mucosal), conjunctival injection, hepatomegaly, splenomegaly or lymphadenopathy; generalized lymphadenopathy (palpable lymph nodes in 4 or more of the following locations: cervical, axillary, inguinal or other with right and left sides considered as separate locations) positive tourniquet test (WHO criterion of 20 or more petechiae per 2.5 cm square)Results were reported positive/negative using the WHO criterion.

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=22 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=22 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=21 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo n=21 Participants A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose Mucosal Hemorrhage	2 participants	1 participants	1 participants	1 participants
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose Rash	3 participants	1 participants	3 participants	0 participants
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose Generalized Rash	1 participants	0 participants	2 participants	0 participants
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose Skin Hemorrhage	0 participants	0 participants	0 participants	1 participants
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose Conj. Hemorrhage	0 participants	0 participants	0 participants	1 participants
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose Conj. Injection 2	2 participants	1 participants	2 participants	1 participants
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose Lymphadenopathy	4 participants	6 participants	7 participants	4 participants
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose Generalized Lymphadenopathy	0 participants	1 participants	0 participants	1 participants
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose Hepatomegaly	2 participants	3 participants	6 participants	4 participants
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose Splemonegaly	0 participants	1 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: Days 0-30 post vaccination periods (total vaccinated cohort)

The case definition of confirmed dengue used in this protocol requires fever (equivalent to an oral temperature ≥38.0ºC/≥ 100.4ºF) for three or more successive days, at least two of the signs or symptoms consistent with "suspected dengue" occurring during the period of fever, at least one clinical laboratory abnormality, and DEN viremia detected by RTqPCR. Cases not meeting all criteria were not considered "confirmed dengue." The percentage of subjects with suspected or confirmed dengue were tabulated by group after each vaccination.

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=22 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=22 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=21 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo n=21 Participants A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort) Dose 1: Confirmed Dengue	0 percentage of participants Interval 0.0 to 15.4	0 percentage of participants Interval 0.0 to 15.4	0 percentage of participants Interval 0.0 to 16.1	0 percentage of participants Interval 0.0 to 16.1
Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort) Dose 2: Suspected Dengue	0 percentage of participants Interval 0.0 to 19.5	0 percentage of participants Interval 0.0 to 17.6	0 percentage of participants Interval 0.0 to 18.5	0 percentage of participants Interval 0.0 to 16.8
Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort) Dose 2: Confirmed Dengue	0 percentage of participants Interval 0.0 to 19.5	0 percentage of participants Interval 0.0 to 17.6	0 percentage of participants Interval 0.0 to 18.5	0 percentage of participants Interval 0.0 to 16.8
Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort) Dose 1: Suspected Dengue	4.5 percentage of participants Interval 0.1 to 22.8	0 percentage of participants Interval 0.0 to 15.4	0 percentage of participants Interval 0.0 to 16.1	4.8 percentage of participants Interval 0.1 to 23.8

SECONDARY outcome

Timeframe: Days 0 to 270

Population: Vaccinated subjects for whom assay results were available.

Sero-response defined as: For initially seronegative(S-) subjects, antibody titer \>=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) \>=4 fold the pre-vacciniation neut. antibody titer

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=16 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=20 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=18 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo n=19 Participants A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose S- (prior to vaccination) DEN-1 Month 1	43.8 percentage of responders Interval 19.8 to 70.1	35.3 percentage of responders Interval 14.2 to 61.7	66.7 percentage of responders Interval 38.4 to 88.2	0 percentage of responders Interval 0.0 to 18.5
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose S- (prior to vaccination) DEN-2 Month 1	87.5 percentage of responders Interval 61.7 to 98.4	70.6 percentage of responders Interval 44.0 to 89.7	86.7 percentage of responders Interval 59.5 to 98.3	0 percentage of responders Interval 0.0 to 20.6
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose S+ (prior to vaccination) DEN-2 Month 1	50 percentage of responders Interval 6.8 to 93.2	33.3 percentage of responders Interval 0.8 to 90.6	33.3 percentage of responders Interval 0.8 to 90.6	0 percentage of responders Interval 0.0 to 70.8
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose S- (prior to vaccination) DEN-3 Month 1	50.0 percentage of responders Interval 24.7 to 75.3	50.0 percentage of responders Interval 24.7 to 75.3	60.0 percentage of responders Interval 32.3 to 83.7	0 percentage of responders Interval 0.0 to 18.5
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose S+(prior to vaccination) DEN-1 Month 1	75 percentage of responders Interval 19.4 to 99.4	0 percentage of responders Interval 0.0 to 70.8	0 percentage of responders Interval 0.0 to 70.8	0 percentage of responders Interval 0.0 to 97.5
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose S+ (prior to vaccination) DEN-3 Month 1	75 percentage of responders Interval 19.4 to 99.4	0 percentage of responders Interval 0.0 to 60.2	33.3 percentage of responders Interval 0.8 to 90.6	0 percentage of responders Interval 0.0 to 97.5
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose S- (prior to vaccination) DEN-4 Month 1	37.5 percentage of responders Interval 15.2 to 64.6	52.9 percentage of responders Interval 27.8 to 77.0	53.3 percentage of responders Interval 26.3 to 78.7	11.1 percentage of responders Interval 1.4 to 34.7
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose S- (prior to vaccination) DEN-5 Month 1	75.0 percentage of responders Interval 19.4 to 99.4	33.3 percentage of responders Interval 0.8 to 90.6	33.3 percentage of responders Interval 0.8 to 90.6	0 percentage of responders Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: Days 0 to 270

Population: Vaccinated subjects for whom assay results were available.

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=16 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=18 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=15 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo n=19 Participants A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued) S- (prior to vaccination) DEN-1 Month 7	92.9 percentage of responders Interval 66.1 to 99.8	73.3 percentage of responders Interval 44.9 to 92.2	83.3 percentage of responders Interval 51.6 to 97.9	5.6 percentage of responders Interval 0.1 to 27.3
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued) S+(prior to vaccination) DEN-1 Month 7	50.0 percentage of responders Interval 1.3 to 98.7	0 percentage of responders Interval 0.0 to 70.8	0 percentage of responders Interval 0.0 to 70.8	0 percentage of responders Interval 0.0 to 97.5
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued) S- (prior to vaccination) DEN-2 Month 7	100 percentage of responders Interval 76.8 to 100.0	80.0 percentage of responders Interval 51.9 to 95.7	100 percentage of responders Interval 73.5 to 100.0	0 percentage of responders Interval 0.0 to 20.6
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued) S+ (prior to vaccination) DEN-2 Month 7	0 percentage of responders Interval 0.0 to 84.2	33.3 percentage of responders Interval 0.8 to 90.6	33.3 percentage of responders Interval 0.8 to 90.6	0 percentage of responders Interval 0.0 to 70.8
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued) S- (prior to vaccination) DEN-3 Month 7	71.4 percentage of responders Interval 41.9 to 91.6	66.7 percentage of responders Interval 38.4 to 88.2	83.3 percentage of responders Interval 51.6 to 97.9	5.6 percentage of responders Interval 0.1 to 27.3
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued) S+ (prior to vaccination) DEN-3 Month 7	50.0 percentage of responders Interval 1.3 to 98.7	33.3 percentage of responders Interval 0.8 to 90.6	33.3 percentage of responders Interval 0.8 to 90.6	0 percentage of responders Interval 0.0 to 97.5
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued) S- (prior to vaccination) DEN-4 Month 7	78.6 percentage of responders Interval 49.2 to 95.3	73.3 percentage of responders Interval 44.9 to 92.2	66.7 percentage of responders Interval 34.9 to 90.1	0 percentage of responders Interval 0.0 to 18.5
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued) S- (prior to vaccination) DEN-5 Month 7	50.0 percentage of responders Interval 1.3 to 98.7	33.3 percentage of responders Interval 0.8 to 90.6	33.3 percentage of responders Interval 0.8 to 90.6	0 percentage of responders Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: Days 0 to 270

For vireimia: Negative = GEQ/µl result is equal to zero Undetermined = GEQ/µL result is below LOD Positive = GEQ/µL result is \>= LOD

Outcome measures

Outcome measures
Measure	Pre-transfection F17 n=22 Participants 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.	Post-transfection F17 n=22 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F17Post vaccine Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Post-transfection F19 n=21 Participants DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Placebo n=21 Participants A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection.
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Dose 2 - Positive	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Dose 2 - Undetermined	1 participants	2 participants	2 participants	1 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Dose 2 - Negative	15 participants	17 participants	16 participants	19 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Dose 2 - Missing	6 participants	3 participants	3 participants	1 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Overall Subject - Positive	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Overall Subject - Undetermined	3 participants	3 participants	3 participants	2 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Overall Subject - Negative	13 participants	16 participants	15 participants	18 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Overall Subject - Missing	6 participants	3 participants	3 participants	1 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Dose 1 - Missing	3 participants	1 participants	2 participants	2 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Dose 2 - Positive	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Dose 2 - Undetermined	0 participants	1 participants	1 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Dose 2 - Negative	15 participants	17 participants	15 participants	18 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Dose 2 - Missing	7 participants	4 participants	5 participants	3 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Overall Subject - Positive	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Overall Subject - Undetermined	0 participants	2 participants	1 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Overall Subject - Negative	15 participants	16 participants	15 participants	18 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Overall Subject - Missing	7 participants	4 participants	5 participants	3 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Dose 1 - Postive	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Dose 1 - Undetermine	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Overall Subject - Negative	16 participants	19 participants	18 participants	20 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Overall Subject - Missing	6 participants	3 participants	3 participants	1 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Dose 1 - Undetermined	1 participants	1 participants	1 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Dose 1 - Negative	17 participants	20 participants	20 participants	21 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Dose 1 - Missing	2 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Dose 2 - Negative	13 participants	19 participants	18 participants	20 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Dose 2 - Missing	6 participants	3 participants	3 participants	1 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Overall Subject - Positive	5 participants	1 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Overall Subject - Undetermined	1 participants	1 participants	1 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Dose 1 - Positive	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Dose 1 - Undetermined	2 participants	1 participants	2 participants	1 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Dose 1 - Negative	18 participants	21 participants	19 participants	20 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN-1 Dose 1 - Missing	2 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Dose 1 - Positive	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Dose 1 - Undetermined	1 participants	1 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 2 Dose 1 - Negative	18 participants	20 participants	19 participants	19 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Dose 1 - Negative	20 participants	22 participants	21 participants	21 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Dose 1 - Missing	2 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Dose 2 - Postive	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Dose 2 - Undetermine	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Dose 2 - Negative	16 participants	19 participants	18 participants	20 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Dose 2 - Missing	6 participants	3 participants	3 participants	1 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Overall Subject - Positive	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 3 Overall Subject - Undetermined	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Dose 1 - Positive	2 participants	1 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Dose 2 - Postive	3 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Dose 2 - Undetermined	0 participants	0 participants	0 participants	0 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Overall Subject - Negative	11 participants	111 participants	17 participants	20 participants
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. DEN- 4 Overall Subject - Missing	5 participants	3 participants	3 participants	1 participants

Adverse Events

Pre-transfection F17

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Post-transfection F17

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Post-transfection F19

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pre-transfection F17 n=22 participants at risk 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine	Post-transfection F17 n=22 participants at risk monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lyophilized, single dose vials and sterile water for injection	Post-transfection F19 n=21 participants at risk 4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines	Placebo n=21 participants at risk A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. 0.5 mL for placebo
Nervous system disorders axonal demyelinating polyneuropathy/bilateral upper and lower extremeties	0.00% 0/22 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	0.00% 0/22 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	4.8% 1/21 • Number of events 1 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	0.00% 0/21 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).
Social circumstances Rule out cerebral bleed secondary to assualt trauma (physical assault)	0.00% 0/22 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	0.00% 0/22 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	0.00% 0/21 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	4.8% 1/21 • Number of events 1 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/22 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	4.5% 1/22 • Number of events 1 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	0.00% 0/21 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	0.00% 0/21 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).
Injury, poisoning and procedural complications Procedural hypertension	0.00% 0/22 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	4.5% 1/22 • Number of events 1 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	0.00% 0/21 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).	0.00% 0/21 • Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).

Other adverse events

Additional Information

Division of Regulated Activities and Compliance Director

United States Army Medical Materiel Development Activity

Phone: 301-619-0317

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place