Trial Outcomes & Findings for A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children (NCT NCT00468858)

Last Updated: 2017-07-02

Results Overview

Incidence of all and grade 3 (prevents normal, everyday activities) solicited local and general symptoms within the 21-day follow-up period (Total vaccinated cohort)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

636 participants

Primary outcome timeframe

Within 21 days (days 0-20) f/up period after each vaccine dose

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	T-DEN-Post-Transfection F17 Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months
Overall Study STARTED	211	212	213
Overall Study COMPLETED	202	202	199
Overall Study NOT COMPLETED	9	10	14

Reasons for withdrawal

Reasons for withdrawal
Measure	T-DEN-Post-Transfection F17 Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	7	4	5
Overall Study Relocation	1	3	3
Overall Study Lost to Follow-up	1	2	5
Overall Study Other	0	0	1

Baseline Characteristics

A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T-DEN-Post-Transfection F17 n=211 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=212 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=213 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	Total n=636 Participants Total of all reporting groups
Age, Continuous	13.8 years STANDARD_DEVIATION 14.10 • n=5 Participants	12.8 years STANDARD_DEVIATION 12.51 • n=7 Participants	13.6 years STANDARD_DEVIATION 13.89 • n=5 Participants	13.4 years STANDARD_DEVIATION 13.50 • n=4 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	114 Participants n=7 Participants	114 Participants n=5 Participants	335 Participants n=4 Participants
Sex: Female, Male Male	104 Participants n=5 Participants	98 Participants n=7 Participants	99 Participants n=5 Participants	301 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	210 Participants n=5 Participants	212 Participants n=7 Participants	213 Participants n=5 Participants	635 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · African heritage / African American	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Race · American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Race · Dominican	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Race · Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · Mixed	9 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Race · Peruvian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Puerto Rican	164 Participants n=5 Participants	166 Participants n=7 Participants	164 Participants n=5 Participants	494 Participants n=4 Participants
Race/Ethnicity, Customized Race · White-Arabic / North African heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · White - Caucasian / European heritage	32 Participants n=5 Participants	34 Participants n=7 Participants	32 Participants n=5 Participants	98 Participants n=4 Participants
Region of Enrollment Puerto Rico	211 Participants n=5 Participants	212 Participants n=7 Participants	213 Participants n=5 Participants	636 Participants n=4 Participants

PRIMARY outcome

Timeframe: Within 21 days (days 0-20) f/up period after each vaccine dose

Incidence of all and grade 3 (prevents normal, everyday activities) solicited local and general symptoms within the 21-day follow-up period (Total vaccinated cohort)

Outcome measures

Outcome measures
Measure	T-DEN-Post-Transfection F17 n=211 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=212 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=213 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	After 31-Day Post Vaccination Period: F17 Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post Vaccination Period: F19 Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post-Vaccination Period: Placebo Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	F19 PI (M6) Post-Transfection F-19 Post-dose 1, month 6	F19 PII (M7) Post-Transfection F-19 Post-dose 2, month 7	Placebo: Pre-vaccination Pre-vaccination (blood sample taken before dose 1)	Placebo: PI (M3) Placebo control Post-dose 1, month 3	Placebo: PI (M6) Placebo control Post-dose 1, month 6	Placebo: PII (M7) Placebo control Post-dose 2, month 7	DEN-2, F19, S- Antibody DEN-2, Group F19, Pre-vaccination status = S-	DEN-2, F19, S+ Antibody DEN-2, Group F19, Pre-vaccination status = S+	DEN-2, F19, Total Antibody DEN-2, Group F19, Pre-vaccination status = Total	DEN-2, Placebo, S- Antibody DEN-2, Placebo group, Pre-vaccination status = S-	DEN-2, Placebo, S+ Antibody DEN-2, Placebo group, Pre-vaccination status = S+	DEN-2, Placebo, Total Antibody DEN-2, Placebo group, Pre-vaccination status = Total	DEN-3, F17, S- Antibody DEN-3, Group F17, Pre-vaccination status = S-	DEN-3, F17, S+ Antibody DEN-3, Group F17, Pre-vaccination status = S+	DEN-3, F17, Total Antibody DEN-3, Group F17, Pre-vaccination status = Total	DEN-3, F19, S- Antibody DEN-3, Group F19, Pre-vaccination status = S-	DEN-3, F19, S+ Antibody DEN-3, Group F19, Pre-vaccination status = S+	DEN-3, F19, Total Antibody DEN-3, Group F19, Pre-vaccination status = Total	DEN-3, Placebo, S- Antibody DEN-3, Placebo group, Pre-vaccination status = S-	DEN-3, Placebo, S+ Antibody DEN-3, Placebo group, Pre-vaccination status = S+	DEN-3, Placebo, Total Antibody DEN-3, Placebo group, Pre-vaccination status = Total	DEN-4, F17, S- Antibody DEN-4, Group F17, Pre-vaccination status = S-	DEN-4, F17, S+ Antibody DEN-4, Group F17, Pre-vaccination status = S+	DEN-4, F17, Total Antibody DEN-4, Group F17, Pre-vaccination status = Total	DEN-4, F19, S- Antibody DEN-4, Group F19, Pre-vaccination status = S-	DEN-4, F19, S+ Antibody DEN-4, Group F19, Pre-vaccination status = S+	DEN-4, F19, Total Antibody DEN-4, Group F19, Pre-vaccination status = Total	DEN-4, Placebo, S- Antibody DEN-4, Placebo group, Pre-vaccination status = S-	DEN-4, Placebo, S+ Antibody DEN-4, Placebo group, Pre-vaccination status = S+	DEN-4, Placebo, Total Antibody DEN-4, Placebo group, Pre-vaccination status = Total
Safety: Incidence of All and Grade 3 Solicited Local Symptoms All Grade 3 AEs	114 number of occurances	98 number of occurances	84 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Pain - All	55 number of occurances	60 number of occurances	48 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Pain - Grade 3	1 number of occurances	0 number of occurances	0 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Redness - All	31 number of occurances	22 number of occurances	20 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Redness - Grade 3	6 number of occurances	2 number of occurances	5 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Swelling - All	3 number of occurances	14 number of occurances	10 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Swelling - Grade 3	3 number of occurances	0 number of occurances	1 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Abdominal Pain - All	28 number of occurances	39 number of occurances	28 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Abdominal Pain - Grade 3	0 number of occurances	1 number of occurances	1 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Fatigue - All	28 number of occurances	33 number of occurances	32 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Fatigue - Grade 3	0 number of occurances	1 number of occurances	0 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Fever - All	103 number of occurances	100 number of occurances	83 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Fever - Grade 3	10 number of occurances	13 number of occurances	9 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Headache - All	75 number of occurances	73 number of occurances	72 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Headache - Grade 3	3 number of occurances	1 number of occurances	6 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Pruritus - All	25 number of occurances	27 number of occurances	19 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Pruritus - Grade 3	0 number of occurances	0 number of occurances	1 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Rash - All	18 number of occurances	20 number of occurances	10 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Rash - Grade 3	0 number of occurances	0 number of occurances	1 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Vomiting - All	24 number of occurances	26 number of occurances	21 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Incidence of All and Grade 3 Solicited Local Symptoms Vomiting - Grade 3	0 number of occurances	1 number of occurances	1 number of occurances	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Within the 31-day (days 0-30) follow-up period after each vaccine dose

Summary of unsolicited Adverse Events within the 31-day post-vaccination period by age group (total vaccinated cohort)

Outcome measures

Outcome measures
Measure	T-DEN-Post-Transfection F17 n=211 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=212 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=213 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	After 31-Day Post Vaccination Period: F17 Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post Vaccination Period: F19 Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post-Vaccination Period: Placebo Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	F19 PI (M6) Post-Transfection F-19 Post-dose 1, month 6	F19 PII (M7) Post-Transfection F-19 Post-dose 2, month 7	Placebo: Pre-vaccination Pre-vaccination (blood sample taken before dose 1)	Placebo: PI (M3) Placebo control Post-dose 1, month 3	Placebo: PI (M6) Placebo control Post-dose 1, month 6	Placebo: PII (M7) Placebo control Post-dose 2, month 7	DEN-2, F19, S- Antibody DEN-2, Group F19, Pre-vaccination status = S-	DEN-2, F19, S+ Antibody DEN-2, Group F19, Pre-vaccination status = S+	DEN-2, F19, Total Antibody DEN-2, Group F19, Pre-vaccination status = Total	DEN-2, Placebo, S- Antibody DEN-2, Placebo group, Pre-vaccination status = S-	DEN-2, Placebo, S+ Antibody DEN-2, Placebo group, Pre-vaccination status = S+	DEN-2, Placebo, Total Antibody DEN-2, Placebo group, Pre-vaccination status = Total	DEN-3, F17, S- Antibody DEN-3, Group F17, Pre-vaccination status = S-	DEN-3, F17, S+ Antibody DEN-3, Group F17, Pre-vaccination status = S+	DEN-3, F17, Total Antibody DEN-3, Group F17, Pre-vaccination status = Total	DEN-3, F19, S- Antibody DEN-3, Group F19, Pre-vaccination status = S-	DEN-3, F19, S+ Antibody DEN-3, Group F19, Pre-vaccination status = S+	DEN-3, F19, Total Antibody DEN-3, Group F19, Pre-vaccination status = Total	DEN-3, Placebo, S- Antibody DEN-3, Placebo group, Pre-vaccination status = S-	DEN-3, Placebo, S+ Antibody DEN-3, Placebo group, Pre-vaccination status = S+	DEN-3, Placebo, Total Antibody DEN-3, Placebo group, Pre-vaccination status = Total	DEN-4, F17, S- Antibody DEN-4, Group F17, Pre-vaccination status = S-	DEN-4, F17, S+ Antibody DEN-4, Group F17, Pre-vaccination status = S+	DEN-4, F17, Total Antibody DEN-4, Group F17, Pre-vaccination status = Total	DEN-4, F19, S- Antibody DEN-4, Group F19, Pre-vaccination status = S-	DEN-4, F19, S+ Antibody DEN-4, Group F19, Pre-vaccination status = S+	DEN-4, F19, Total Antibody DEN-4, Group F19, Pre-vaccination status = Total	DEN-4, Placebo, S- Antibody DEN-4, Placebo group, Pre-vaccination status = S-	DEN-4, Placebo, S+ Antibody DEN-4, Placebo group, Pre-vaccination status = S+	DEN-4, Placebo, Total Antibody DEN-4, Placebo group, Pre-vaccination status = Total
Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period At least one symptom - age 1 - 4 years	52 Participants	60 Participants	65 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period At least one symptom - age 5 - 50	44 Participants	40 Participants	40 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period Subject showing no unsolicited symptoms	115 Participants	112 Participants	108 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 6 months + 30 day follow-up period after last vaccine dose

Summary of SAEs, 6 months + 30 day follow-up period after last vaccine dose

Outcome measures

Outcome measures
Measure	T-DEN-Post-Transfection F17 n=211 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=212 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=213 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	After 31-Day Post Vaccination Period: F17 Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post Vaccination Period: F19 Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post-Vaccination Period: Placebo Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	F19 PI (M6) Post-Transfection F-19 Post-dose 1, month 6	F19 PII (M7) Post-Transfection F-19 Post-dose 2, month 7	Placebo: Pre-vaccination Pre-vaccination (blood sample taken before dose 1)	Placebo: PI (M3) Placebo control Post-dose 1, month 3	Placebo: PI (M6) Placebo control Post-dose 1, month 6	Placebo: PII (M7) Placebo control Post-dose 2, month 7	DEN-2, F19, S- Antibody DEN-2, Group F19, Pre-vaccination status = S-	DEN-2, F19, S+ Antibody DEN-2, Group F19, Pre-vaccination status = S+	DEN-2, F19, Total Antibody DEN-2, Group F19, Pre-vaccination status = Total	DEN-2, Placebo, S- Antibody DEN-2, Placebo group, Pre-vaccination status = S-	DEN-2, Placebo, S+ Antibody DEN-2, Placebo group, Pre-vaccination status = S+	DEN-2, Placebo, Total Antibody DEN-2, Placebo group, Pre-vaccination status = Total	DEN-3, F17, S- Antibody DEN-3, Group F17, Pre-vaccination status = S-	DEN-3, F17, S+ Antibody DEN-3, Group F17, Pre-vaccination status = S+	DEN-3, F17, Total Antibody DEN-3, Group F17, Pre-vaccination status = Total	DEN-3, F19, S- Antibody DEN-3, Group F19, Pre-vaccination status = S-	DEN-3, F19, S+ Antibody DEN-3, Group F19, Pre-vaccination status = S+	DEN-3, F19, Total Antibody DEN-3, Group F19, Pre-vaccination status = Total	DEN-3, Placebo, S- Antibody DEN-3, Placebo group, Pre-vaccination status = S-	DEN-3, Placebo, S+ Antibody DEN-3, Placebo group, Pre-vaccination status = S+	DEN-3, Placebo, Total Antibody DEN-3, Placebo group, Pre-vaccination status = Total	DEN-4, F17, S- Antibody DEN-4, Group F17, Pre-vaccination status = S-	DEN-4, F17, S+ Antibody DEN-4, Group F17, Pre-vaccination status = S+	DEN-4, F17, Total Antibody DEN-4, Group F17, Pre-vaccination status = Total	DEN-4, F19, S- Antibody DEN-4, Group F19, Pre-vaccination status = S-	DEN-4, F19, S+ Antibody DEN-4, Group F19, Pre-vaccination status = S+	DEN-4, F19, Total Antibody DEN-4, Group F19, Pre-vaccination status = Total	DEN-4, Placebo, S- Antibody DEN-4, Placebo group, Pre-vaccination status = S-	DEN-4, Placebo, S+ Antibody DEN-4, Placebo group, Pre-vaccination status = S+	DEN-4, Placebo, Total Antibody DEN-4, Placebo group, Pre-vaccination status = Total
Safety: Occurrence of Serious Adverse Events (SAEs) Subjects with at least 1 SAE - not related	8 Participants	4 Participants	11 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Occurrence of Serious Adverse Events (SAEs) Subject showing no SAE symptoms	203 Participants	208 Participants	202 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Safety: Occurrence of Serious Adverse Events (SAEs) Subjects with at least 1 SAE - related	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 31-day (days 0-30) post-vaccination period and after 31-day period

Incidence of suspected and confirmed dengue reported during the 31-day (Days 0-30) post-vaccination period and after the 31-day period

Outcome measures

Outcome measures
Measure	T-DEN-Post-Transfection F17 n=211 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=212 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=213 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	After 31-Day Post Vaccination Period: F17 n=211 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post Vaccination Period: F19 n=212 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post-Vaccination Period: Placebo n=213 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	F19 PI (M6) Post-Transfection F-19 Post-dose 1, month 6	F19 PII (M7) Post-Transfection F-19 Post-dose 2, month 7	Placebo: Pre-vaccination Pre-vaccination (blood sample taken before dose 1)	Placebo: PI (M3) Placebo control Post-dose 1, month 3	Placebo: PI (M6) Placebo control Post-dose 1, month 6	Placebo: PII (M7) Placebo control Post-dose 2, month 7	DEN-2, F19, S- Antibody DEN-2, Group F19, Pre-vaccination status = S-	DEN-2, F19, S+ Antibody DEN-2, Group F19, Pre-vaccination status = S+	DEN-2, F19, Total Antibody DEN-2, Group F19, Pre-vaccination status = Total	DEN-2, Placebo, S- Antibody DEN-2, Placebo group, Pre-vaccination status = S-	DEN-2, Placebo, S+ Antibody DEN-2, Placebo group, Pre-vaccination status = S+	DEN-2, Placebo, Total Antibody DEN-2, Placebo group, Pre-vaccination status = Total	DEN-3, F17, S- Antibody DEN-3, Group F17, Pre-vaccination status = S-	DEN-3, F17, S+ Antibody DEN-3, Group F17, Pre-vaccination status = S+	DEN-3, F17, Total Antibody DEN-3, Group F17, Pre-vaccination status = Total	DEN-3, F19, S- Antibody DEN-3, Group F19, Pre-vaccination status = S-	DEN-3, F19, S+ Antibody DEN-3, Group F19, Pre-vaccination status = S+	DEN-3, F19, Total Antibody DEN-3, Group F19, Pre-vaccination status = Total	DEN-3, Placebo, S- Antibody DEN-3, Placebo group, Pre-vaccination status = S-	DEN-3, Placebo, S+ Antibody DEN-3, Placebo group, Pre-vaccination status = S+	DEN-3, Placebo, Total Antibody DEN-3, Placebo group, Pre-vaccination status = Total	DEN-4, F17, S- Antibody DEN-4, Group F17, Pre-vaccination status = S-	DEN-4, F17, S+ Antibody DEN-4, Group F17, Pre-vaccination status = S+	DEN-4, F17, Total Antibody DEN-4, Group F17, Pre-vaccination status = Total	DEN-4, F19, S- Antibody DEN-4, Group F19, Pre-vaccination status = S-	DEN-4, F19, S+ Antibody DEN-4, Group F19, Pre-vaccination status = S+	DEN-4, F19, Total Antibody DEN-4, Group F19, Pre-vaccination status = Total	DEN-4, Placebo, S- Antibody DEN-4, Placebo group, Pre-vaccination status = S-	DEN-4, Placebo, S+ Antibody DEN-4, Placebo group, Pre-vaccination status = S+	DEN-4, Placebo, Total Antibody DEN-4, Placebo group, Pre-vaccination status = Total
Incidence of Suspected and Laboratory Confirmed Dengue Dose 1: Suspected dengue fever	3 dengue fever cases	3 dengue fever cases	0 dengue fever cases	3 dengue fever cases	3 dengue fever cases	3 dengue fever cases	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Incidence of Suspected and Laboratory Confirmed Dengue Dose 1: Suspected with med. attention	3 dengue fever cases	3 dengue fever cases	0 dengue fever cases	3 dengue fever cases	3 dengue fever cases	3 dengue fever cases	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Incidence of Suspected and Laboratory Confirmed Dengue Dose 1: Confirmed dengue fever	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Incidence of Suspected and Laboratory Confirmed Dengue Dose 2: Suspected dengue fever	0 dengue fever cases	1 dengue fever cases	1 dengue fever cases	1 dengue fever cases	1 dengue fever cases	0 dengue fever cases	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Incidence of Suspected and Laboratory Confirmed Dengue Dose 2: Suspected with med. attention	0 dengue fever cases	1 dengue fever cases	1 dengue fever cases	1 dengue fever cases	1 dengue fever cases	0 dengue fever cases	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Incidence of Suspected and Laboratory Confirmed Dengue Dose 2: Confirmed dengue fever	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Incidence of Suspected and Laboratory Confirmed Dengue Overall Subject: Suspected dengue fever	3 dengue fever cases	4 dengue fever cases	1 dengue fever cases	4 dengue fever cases	4 dengue fever cases	3 dengue fever cases	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Incidence of Suspected and Laboratory Confirmed Dengue Overall Subject: Suspected with med. attention	3 dengue fever cases	4 dengue fever cases	1 dengue fever cases	4 dengue fever cases	4 dengue fever cases	3 dengue fever cases	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Incidence of Suspected and Laboratory Confirmed Dengue Overall Subject: Confirmed dengue fever	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	0 dengue fever cases	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: at month 7 (one month post dose 2)

Comparison of F17 and F19 formulations in terms of GMTs at month 7 (one month post dose 2) for each DEN type, -unprimed and primed subjects

Outcome measures

Outcome measures
Measure	T-DEN-Post-Transfection F17 n=211 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=212 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	After 31-Day Post Vaccination Period: F17 Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post Vaccination Period: F19 Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post-Vaccination Period: Placebo Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	F19 PI (M6) Post-Transfection F-19 Post-dose 1, month 6	F19 PII (M7) Post-Transfection F-19 Post-dose 2, month 7	Placebo: Pre-vaccination Pre-vaccination (blood sample taken before dose 1)	Placebo: PI (M3) Placebo control Post-dose 1, month 3	Placebo: PI (M6) Placebo control Post-dose 1, month 6	Placebo: PII (M7) Placebo control Post-dose 2, month 7	DEN-2, F19, S- Antibody DEN-2, Group F19, Pre-vaccination status = S-	DEN-2, F19, S+ Antibody DEN-2, Group F19, Pre-vaccination status = S+	DEN-2, F19, Total Antibody DEN-2, Group F19, Pre-vaccination status = Total	DEN-2, Placebo, S- Antibody DEN-2, Placebo group, Pre-vaccination status = S-	DEN-2, Placebo, S+ Antibody DEN-2, Placebo group, Pre-vaccination status = S+	DEN-2, Placebo, Total Antibody DEN-2, Placebo group, Pre-vaccination status = Total	DEN-3, F17, S- Antibody DEN-3, Group F17, Pre-vaccination status = S-	DEN-3, F17, S+ Antibody DEN-3, Group F17, Pre-vaccination status = S+	DEN-3, F17, Total Antibody DEN-3, Group F17, Pre-vaccination status = Total	DEN-3, F19, S- Antibody DEN-3, Group F19, Pre-vaccination status = S-	DEN-3, F19, S+ Antibody DEN-3, Group F19, Pre-vaccination status = S+	DEN-3, F19, Total Antibody DEN-3, Group F19, Pre-vaccination status = Total	DEN-3, Placebo, S- Antibody DEN-3, Placebo group, Pre-vaccination status = S-	DEN-3, Placebo, S+ Antibody DEN-3, Placebo group, Pre-vaccination status = S+	DEN-3, Placebo, Total Antibody DEN-3, Placebo group, Pre-vaccination status = Total	DEN-4, F17, S- Antibody DEN-4, Group F17, Pre-vaccination status = S-	DEN-4, F17, S+ Antibody DEN-4, Group F17, Pre-vaccination status = S+	DEN-4, F17, Total Antibody DEN-4, Group F17, Pre-vaccination status = Total	DEN-4, F19, S- Antibody DEN-4, Group F19, Pre-vaccination status = S-	DEN-4, F19, S+ Antibody DEN-4, Group F19, Pre-vaccination status = S+	DEN-4, F19, Total Antibody DEN-4, Group F19, Pre-vaccination status = Total	DEN-4, Placebo, S- Antibody DEN-4, Placebo group, Pre-vaccination status = S-	DEN-4, Placebo, S+ Antibody DEN-4, Placebo group, Pre-vaccination status = S+	DEN-4, Placebo, Total Antibody DEN-4, Placebo group, Pre-vaccination status = Total
GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects Unprimed Subjects: DEN-1	130.9 titers Interval 84.1 to 203.7	84.4 titers Interval 43.6 to 163.5	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects Unprimed Subjects: DEN-2	218.6 titers Interval 125.3 to 381.3	215.2 titers Interval 116.7 to 396.7	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects Unprimed Subjects: DEN-3	124.5 titers Interval 76.9 to 201.6	60.3 titers Interval 33.0 to 110.2	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects Unprimed Subjects: DEN-4	377.7 titers Interval 249.4 to 572.0	105.9 titers Interval 55.8 to 201.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects Primed Subjects: DEN-1	1412.8 titers Interval 1191.5 to 1675.3	1324.1 titers Interval 1104.1 to 1587.9	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects Primed Subjects: DEN-2	1514.4 titers Interval 1322.2 to 1734.6	1338.5 titers Interval 1105.6 to 1620.6	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects Primed Subjects: DEN-3	1130.0 titers Interval 920.0 to 1388.0	901.4 titers Interval 707.6 to 1148.3	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects Primed Subjects: DEN-4	1228.4 titers Interval 1014.1 to 1488.0	1020.8 titers Interval 809.5 to 1287.4	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-vaccination, at post dose 1, months 3 and 6 and post dose 2, month 7

Monovalent, bivalent, trivalent and tetravalent response for DEN neut. antibodies for unprimed and primed subjects

Outcome measures

Outcome measures
Measure	T-DEN-Post-Transfection F17 n=86 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=83 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=82 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	After 31-Day Post Vaccination Period: F17 n=82 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post Vaccination Period: F19 n=61 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post-Vaccination Period: Placebo n=60 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	F19 PI (M6) n=59 Participants Post-Transfection F-19 Post-dose 1, month 6	F19 PII (M7) n=59 Participants Post-Transfection F-19 Post-dose 2, month 7	Placebo: Pre-vaccination n=74 Participants Pre-vaccination (blood sample taken before dose 1)	Placebo: PI (M3) n=71 Participants Placebo control Post-dose 1, month 3	Placebo: PI (M6) n=69 Participants Placebo control Post-dose 1, month 6	Placebo: PII (M7) n=68 Participants Placebo control Post-dose 2, month 7	DEN-2, F19, S- Antibody DEN-2, Group F19, Pre-vaccination status = S-	DEN-2, F19, S+ Antibody DEN-2, Group F19, Pre-vaccination status = S+	DEN-2, F19, Total Antibody DEN-2, Group F19, Pre-vaccination status = Total	DEN-2, Placebo, S- Antibody DEN-2, Placebo group, Pre-vaccination status = S-	DEN-2, Placebo, S+ Antibody DEN-2, Placebo group, Pre-vaccination status = S+	DEN-2, Placebo, Total Antibody DEN-2, Placebo group, Pre-vaccination status = Total	DEN-3, F17, S- Antibody DEN-3, Group F17, Pre-vaccination status = S-	DEN-3, F17, S+ Antibody DEN-3, Group F17, Pre-vaccination status = S+	DEN-3, F17, Total Antibody DEN-3, Group F17, Pre-vaccination status = Total	DEN-3, F19, S- Antibody DEN-3, Group F19, Pre-vaccination status = S-	DEN-3, F19, S+ Antibody DEN-3, Group F19, Pre-vaccination status = S+	DEN-3, F19, Total Antibody DEN-3, Group F19, Pre-vaccination status = Total	DEN-3, Placebo, S- Antibody DEN-3, Placebo group, Pre-vaccination status = S-	DEN-3, Placebo, S+ Antibody DEN-3, Placebo group, Pre-vaccination status = S+	DEN-3, Placebo, Total Antibody DEN-3, Placebo group, Pre-vaccination status = Total	DEN-4, F17, S- Antibody DEN-4, Group F17, Pre-vaccination status = S-	DEN-4, F17, S+ Antibody DEN-4, Group F17, Pre-vaccination status = S+	DEN-4, F17, Total Antibody DEN-4, Group F17, Pre-vaccination status = Total	DEN-4, F19, S- Antibody DEN-4, Group F19, Pre-vaccination status = S-	DEN-4, F19, S+ Antibody DEN-4, Group F19, Pre-vaccination status = S+	DEN-4, F19, Total Antibody DEN-4, Group F19, Pre-vaccination status = Total	DEN-4, Placebo, S- Antibody DEN-4, Placebo group, Pre-vaccination status = S-	DEN-4, Placebo, S+ Antibody DEN-4, Placebo group, Pre-vaccination status = S+	DEN-4, Placebo, Total Antibody DEN-4, Placebo group, Pre-vaccination status = Total
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes Unprimed: Valence=None	100 % of subjects Interval 95.8 to 100.0	53 % of subjects Interval 41.7 to 64.1	52.4 % of subjects Interval 41.1 to 63.6	2.4 % of subjects Interval 0.3 to 8.5	100 % of subjects Interval 94.1 to 100.0	50 % of subjects Interval 36.8 to 63.2	50.8 % of subjects Interval 37.5 to 64.1	5.1 % of subjects Interval 1.1 to 14.1	100 % of subjects Interval 95.1 to 100.0	95.8 % of subjects Interval 88.1 to 99.1	92.8 % of subjects Interval 83.9 to 97.6	94.1 % of subjects Interval 85.6 to 98.4	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes Unprimed: Valence=Monovalent	0 % of subjects Interval 0.0 to 0.0	24.1 % of subjects Interval 15.4 to 34.7	23.2 % of subjects Interval 14.6 to 33.8	1.2 % of subjects Interval 0.0 to 6.6	0 % of subjects Interval 0.0 to 0.0	23.3 % of subjects Interval 13.4 to 36.0	27.1 % of subjects Interval 16.4 to 40.3	5.1 % of subjects Interval 1.1 to 14.1	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	1.4 % of subjects Interval 0.0 to 7.8	1.5 % of subjects Interval 0.0 to 7.9	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes Unprimed: Valence=Bivalent	0 % of subjects Interval 0.0 to 0.0	4.8 % of subjects Interval 1.3 to 11.9	7.3 % of subjects Interval 2.7 to 15.2	2.4 % of subjects Interval 0.3 to 8.5	0 % of subjects Interval 0.0 to 0.0	5 % of subjects Interval 1.0 to 13.9	5.1 % of subjects Interval 1.1 to 14.1	8.5 % of subjects Interval 2.8 to 18.7	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	2.9 % of subjects Interval 0.4 to 10.1	1.5 % of subjects Interval 0.0 to 7.9	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes Unprimed: Valence=Trivalent	0 % of subjects Interval 0.0 to 0.0	7.2 % of subjects Interval 2.7 to 15.1	7.3 % of subjects Interval 2.7 to 15.2	7.3 % of subjects Interval 2.7 to 15.2	0 % of subjects Interval 0.0 to 0.0	1.7 % of subjects Interval 0.0 to 8.9	3.4 % of subjects Interval 0.4 to 11.7	6.8 % of subjects Interval 1.9 to 16.5	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes Unprimed: Valence=Tetravalent	0 % of subjects Interval 0.0 to 0.0	10.8 % of subjects Interval 5.1 to 19.6	9.8 % of subjects Interval 4.3 to 18.3	86.6 % of subjects Interval 77.3 to 93.1	0 % of subjects Interval 0.0 to 0.0	20 % of subjects Interval 10.8 to 32.3	13.6 % of subjects Interval 6.0 to 25.0	74.6 % of subjects Interval 61.6 to 85.0	0 % of subjects Interval 0.0 to 0.0	4.2 % of subjects Interval 0.9 to 11.9	2.9 % of subjects Interval 0.4 to 10.1	2.9 % of subjects Interval 0.4 to 10.2	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes Primed: Valence=Monovalent	3.3 % of subjects Interval 0.7 to 9.3	1.1 % of subjects Interval 0.0 to 6.2	1.1 % of subjects Interval 0.0 to 6.2	0 % of subjects Interval 0.0 to 0.0	2.1 % of subjects Interval 0.3 to 7.5	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	1.1 % of subjects Interval 0.0 to 6.0	8.9 % of subjects Interval 4.2 to 16.2	3 % of subjects Interval 0.6 to 8.6	3 % of subjects Interval 0.6 to 8.6	2 % of subjects Interval 0.2 to 7.1	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes Primed: Valence=Trivalent	1.1 % of subjects Interval 0.0 to 6.0	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	2.1 % of subjects Interval 0.3 to 7.5	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	2 % of subjects Interval 0.2 to 7.1	1 % of subjects Interval 0.0 to 5.5	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes Primed: Valence=Bivalent	0 % of subjects Interval 0.0 to 0.0	1.1 % of subjects Interval 0.0 to 6.2	1.1 % of subjects Interval 0.0 to 6.2	0 % of subjects Interval 0.0 to 0.0	3.2 % of subjects Interval 0.7 to 9.0	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	1 % of subjects Interval 0.0 to 5.4	2 % of subjects Interval 0.2 to 7.1	0 % of subjects Interval 0.0 to 0.0	1 % of subjects Interval 0.0 to 5.5	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes Primed: Valence=Tetravalent	96.5 % of subjects Interval 89.1 to 98.8	96.6 % of subjects Interval 90.4 to 99.3	97.7 % of subjects Interval 91.9 to 99.7	100 % of subjects Interval 95.8 to 100.0	92.6 % of subjects Interval 85.3 to 97.0	98.9 % of subjects Interval 94.2 to 100.0	100 % of subjects Interval 96.0 to 100.0	98.9 % of subjects Interval 94.0 to 100.0	90.1 % of subjects Interval 82.5 to 95.1	91.9 % of subjects Interval 84.7 to 96.4	89.9 % of subjects Interval 82.2 to 95.0	90.9 % of subjects Interval 84.4 to 95.8	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes Primed: Valence=None	0 % of subjects Interval 0.0 to 0.0	1.1 % of subjects Interval 0.0 to 6.2	1.1 % of subjects Interval 0.0 to 6.2	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	1.1 % of subjects Interval 0.0 to 5.8	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	0 % of subjects Interval 0.0 to 0.0	3 % of subjects Interval 0.6 to 8.6	5.1 % of subjects Interval 1.7 to 11.4	5.1 % of subjects Interval 1.7 to 11.4	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-accination, at post dose 1, months 3 and 6 and post dose 2, month 7

Seropositivity rates for DEN neut. antibodies for unprimed and primed subjects

Outcome measures

Outcome measures
Measure	T-DEN-Post-Transfection F17 n=86 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=83 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=82 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	After 31-Day Post Vaccination Period: F17 n=82 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post Vaccination Period: F19 n=61 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post-Vaccination Period: Placebo n=60 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	F19 PI (M6) n=59 Participants Post-Transfection F-19 Post-dose 1, month 6	F19 PII (M7) n=59 Participants Post-Transfection F-19 Post-dose 2, month 7	Placebo: Pre-vaccination n=74 Participants Pre-vaccination (blood sample taken before dose 1)	Placebo: PI (M3) n=71 Participants Placebo control Post-dose 1, month 3	Placebo: PI (M6) n=69 Participants Placebo control Post-dose 1, month 6	Placebo: PII (M7) n=68 Participants Placebo control Post-dose 2, month 7	DEN-2, F19, S- Antibody DEN-2, Group F19, Pre-vaccination status = S-	DEN-2, F19, S+ Antibody DEN-2, Group F19, Pre-vaccination status = S+	DEN-2, F19, Total Antibody DEN-2, Group F19, Pre-vaccination status = Total	DEN-2, Placebo, S- Antibody DEN-2, Placebo group, Pre-vaccination status = S-	DEN-2, Placebo, S+ Antibody DEN-2, Placebo group, Pre-vaccination status = S+	DEN-2, Placebo, Total Antibody DEN-2, Placebo group, Pre-vaccination status = Total	DEN-3, F17, S- Antibody DEN-3, Group F17, Pre-vaccination status = S-	DEN-3, F17, S+ Antibody DEN-3, Group F17, Pre-vaccination status = S+	DEN-3, F17, Total Antibody DEN-3, Group F17, Pre-vaccination status = Total	DEN-3, F19, S- Antibody DEN-3, Group F19, Pre-vaccination status = S-	DEN-3, F19, S+ Antibody DEN-3, Group F19, Pre-vaccination status = S+	DEN-3, F19, Total Antibody DEN-3, Group F19, Pre-vaccination status = Total	DEN-3, Placebo, S- Antibody DEN-3, Placebo group, Pre-vaccination status = S-	DEN-3, Placebo, S+ Antibody DEN-3, Placebo group, Pre-vaccination status = S+	DEN-3, Placebo, Total Antibody DEN-3, Placebo group, Pre-vaccination status = Total	DEN-4, F17, S- Antibody DEN-4, Group F17, Pre-vaccination status = S-	DEN-4, F17, S+ Antibody DEN-4, Group F17, Pre-vaccination status = S+	DEN-4, F17, Total Antibody DEN-4, Group F17, Pre-vaccination status = Total	DEN-4, F19, S- Antibody DEN-4, Group F19, Pre-vaccination status = S-	DEN-4, F19, S+ Antibody DEN-4, Group F19, Pre-vaccination status = S+	DEN-4, F19, Total Antibody DEN-4, Group F19, Pre-vaccination status = Total	DEN-4, Placebo, S- Antibody DEN-4, Placebo group, Pre-vaccination status = S-	DEN-4, Placebo, S+ Antibody DEN-4, Placebo group, Pre-vaccination status = S+	DEN-4, Placebo, Total Antibody DEN-4, Placebo group, Pre-vaccination status = Total
Percent of Subjects With Neut. Sero-response to Each DEN Serotype Primed: DEN-4, >10 ED50	96.7 percent of subject with attribute Interval 90.7 to 99.3	98.9 percent of subject with attribute Interval 93.8 to 100.0	98.9 percent of subject with attribute Interval 93.8 to 100.0	100 percent of subject with attribute Interval 95.8 to 100.0	98.9 percent of subject with attribute Interval 94.2 to 100.0	98.9 percent of subject with attribute Interval 94.2 to 100.0	100 percent of subject with attribute Interval 96.0 to 100.0	98.9 percent of subject with attribute Interval 94.0 to 100.0	92.1 percent of subject with attribute Interval 85.0 to 96.5	93.9 percent of subject with attribute Interval 87.3 to 97.7	91.9 percent of subject with attribute Interval 84.7 to 96.4	92.9 percent of subject with attribute Interval 86.0 to 97.1	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Sero-response to Each DEN Serotype Unprimed: DEN-1, >10 ED50	0.0 percent of subject with attribute Interval 0.0 to 4.2	20.5 percent of subject with attribute Interval 12.4 to 30.8	22.0 percent of subject with attribute Interval 13.6 to 32.5	95.1 percent of subject with attribute Interval 88.0 to 98.7	0.0 percent of subject with attribute Interval 0.0 to 5.9	26.7 percent of subject with attribute Interval 16.1 to 39.7	18.6 percent of subject with attribute Interval 9.7 to 30.9	83.1 percent of subject with attribute Interval 71.0 to 91.6	0.0 percent of subject with attribute Interval 0.0 to 4.9	4.2 percent of subject with attribute Interval 0.9 to 11.9	4.3 percent of subject with attribute Interval 0.9 to 12.2	4.4 percent of subject with attribute Interval 0.9 to 12.4	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Sero-response to Each DEN Serotype Unprimed: DEN-2, >10 ED50	0 percent of subject with attribute Interval 0.0 to 0.0	26.5 percent of subject with attribute Interval 17.4 to 37.3	28.0 percent of subject with attribute Interval 18.7 to 39.1	89.0 percent of subject with attribute Interval 80.2 to 94.9	0.0 percent of subject with attribute Interval 0.0 to 5.9	43.3 percent of subject with attribute Interval 30.6 to 56.8	40.7 percent of subject with attribute Interval 28.1 to 54.3	93.2 percent of subject with attribute Interval 83.5 to 98.1	0.0 percent of subject with attribute Interval 0.0 to 4.9	4.2 percent of subject with attribute Interval 0.9 to 11.9	4.3 percent of subject with attribute Interval 0.9 to 12.2	2.9 percent of subject with attribute Interval 0.4 to 10.2	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Sero-response to Each DEN Serotype Unprimed: DEN-3, >10 ED50	0.0 percent of subject with attribute Interval 0.0 to 4.2	14.5 percent of subject with attribute Interval 7.7 to 23.9	15.9 percent of subject with attribute Interval 8.7 to 25.6	92.7 percent of subject with attribute Interval 84.8 to 97.3	0.0 percent of subject with attribute Interval 0.0 to 5.9	21.7 percent of subject with attribute Interval 12.1 to 34.2	16.9 percent of subject with attribute Interval 8.4 to 29.0	78.0 percent of subject with attribute Interval 65.3 to 87.7	0.0 percent of subject with attribute Interval 0.0 to 4.9	4.2 percent of subject with attribute Interval 0.9 to 11.9	7.2 percent of subject with attribute Interval 2.4 to 16.1	4.4 percent of subject with attribute Interval 0.9 to 12.4	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Sero-response to Each DEN Serotype Unprimed: DEN-4, >10 ED50	0.0 percent of subject with attribute Interval 0.0 to 4.2	37.3 percent of subject with attribute Interval 27.0 to 48.7	32.9 percent of subject with attribute Interval 22.9 to 44.2	97.6 percent of subject with attribute Interval 91.5 to 99.7	0.0 percent of subject with attribute Interval 0.0 to 5.9	26.7 percent of subject with attribute Interval 16.1 to 39.7	25.4 percent of subject with attribute Interval 15.0 to 38.4	86.4 percent of subject with attribute Interval 75.0 to 94.0	0.0 percent of subject with attribute Interval 0.0 to 4.9	4.2 percent of subject with attribute Interval 0.9 to 11.9	2.9 percent of subject with attribute Interval 0.4 to 10.1	4.4 percent of subject with attribute Interval 0.9 to 12.4	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Sero-response to Each DEN Serotype Primed: DEN-1, >10 ED50	97.8 percent of subject with attribute Interval 92.3 to 99.7	97.7 percent of subject with attribute Interval 92.0 to 99.7	98.9 percent of subject with attribute Interval 93.8 to 100.0	100 percent of subject with attribute Interval 95.8 to 100.0	96.8 percent of subject with attribute Interval 91.0 to 99.3	98.9 percent of subject with attribute Interval 94.2 to 100.0	100 percent of subject with attribute Interval 96.0 to 100.0	100 percent of subject with attribute Interval 96.0 to 100.0	94.1 percent of subject with attribute Interval 87.5 to 97.8	94.9 percent of subject with attribute Interval 88.6 to 98.3	92.9 percent of subject with attribute Interval 86.0 to 97.1	90.9 percent of subject with attribute Interval 83.4 to 95.8	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Sero-response to Each DEN Serotype Primed: DEN-2, >10 ED50	97.8 percent of subject with attribute Interval 92.3 to 99.7	96.6 percent of subject with attribute Interval 90.4 to 99.3	97.7 percent of subject with attribute Interval 91.9 to 99.7	100 percent of subject with attribute Interval 95.8 to 100.0	96.8 percent of subject with attribute Interval 91.0 to 99.3	98.9 percent of subject with attribute Interval 94.2 to 100.0	100 percent of subject with attribute Interval 96.0 to 100.0	98.9 percent of subject with attribute Interval 94.0 to 100.0	95.0 percent of subject with attribute Interval 88.8 to 98.4	93.9 percent of subject with attribute Interval 87.3 to 97.7	92.9 percent of subject with attribute Interval 86.0 to 97.1	93.9 percent of subject with attribute Interval 87.3 to 97.7	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Percent of Subjects With Neut. Sero-response to Each DEN Serotype Primed: DEN-3, >10 ED50	96.7 percent of subject with attribute Interval 90.7 to 99.3	96.6 percent of subject with attribute Interval 90.4 to 99.3	97.7 percent of subject with attribute Interval 91.9 to 99.7	100 percent of subject with attribute Interval 95.8 to 100.0	92.6 percent of subject with attribute Interval 85.3 to 97.0	98.9 percent of subject with attribute Interval 94.2 to 100.0	100 percent of subject with attribute Interval 96.0 to 100.0	98.9 percent of subject with attribute Interval 94.0 to 100.0	90.1 percent of subject with attribute Interval 82.5 to 95.1	91.9 percent of subject with attribute Interval 84.7 to 96.4	90.9 percent of subject with attribute Interval 83.4 to 95.8	92.9 percent of subject with attribute Interval 86.0 to 97.1	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: at month 3, post dose 1

Vaccine response for DEN-1, DEN-2, DEN-3 and DEN-4 antibody S- = seronegative subjects (antibody titer \<10 ED50 for DEN-1, 2, 3, and 4 prior to vaccination; S+ = Seropositive subjects (antibody titer \>10 ED50 for DEN-1, 2, 3 and 4 prior to vaccination; Total = subjects either seropositive or seronegative at pre-vaccination Vaccine response defined as: For initially seronegative subjects, antibody titer \>10 ED50 at PI(M3) and for initially seropositive subjects: antibody titer at PI(m3) \>4 fold the pre-vaccination antibody titer

Outcome measures

Outcome measures
Measure	T-DEN-Post-Transfection F17 n=84 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=37 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=121 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	After 31-Day Post Vaccination Period: F17 n=63 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post Vaccination Period: F19 n=38 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post-Vaccination Period: Placebo n=101 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	F19 PI (M6) n=77 Participants Post-Transfection F-19 Post-dose 1, month 6	F19 PII (M7) n=43 Participants Post-Transfection F-19 Post-dose 2, month 7	Placebo: Pre-vaccination n=120 Participants Pre-vaccination (blood sample taken before dose 1)	Placebo: PI (M3) n=85 Participants Placebo control Post-dose 1, month 3	Placebo: PI (M6) n=33 Participants Placebo control Post-dose 1, month 6	Placebo: PII (M7) n=118 Participants Placebo control Post-dose 2, month 7	DEN-2, F19, S- n=63 Participants Antibody DEN-2, Group F19, Pre-vaccination status = S-	DEN-2, F19, S+ n=45 Participants Antibody DEN-2, Group F19, Pre-vaccination status = S+	DEN-2, F19, Total n=108 Participants Antibody DEN-2, Group F19, Pre-vaccination status = Total	DEN-2, Placebo, S- n=76 Participants Antibody DEN-2, Placebo group, Pre-vaccination status = S-	DEN-2, Placebo, S+ n=43 Participants Antibody DEN-2, Placebo group, Pre-vaccination status = S+	DEN-2, Placebo, Total n=119 Participants Antibody DEN-2, Placebo group, Pre-vaccination status = Total	DEN-3, F17, S- n=85 Participants Antibody DEN-3, Group F17, Pre-vaccination status = S-	DEN-3, F17, S+ n=36 Participants Antibody DEN-3, Group F17, Pre-vaccination status = S+	DEN-3, F17, Total n=121 Participants Antibody DEN-3, Group F17, Pre-vaccination status = Total	DEN-3, F19, S- n=66 Participants Antibody DEN-3, Group F19, Pre-vaccination status = S-	DEN-3, F19, S+ n=45 Participants Antibody DEN-3, Group F19, Pre-vaccination status = S+	DEN-3, F19, Total n=111 Participants Antibody DEN-3, Group F19, Pre-vaccination status = Total	DEN-3, Placebo, S- n=81 Participants Antibody DEN-3, Placebo group, Pre-vaccination status = S-	DEN-3, Placebo, S+ n=39 Participants Antibody DEN-3, Placebo group, Pre-vaccination status = S+	DEN-3, Placebo, Total n=120 Participants Antibody DEN-3, Placebo group, Pre-vaccination status = Total	DEN-4, F17, S- n=85 Participants Antibody DEN-4, Group F17, Pre-vaccination status = S-	DEN-4, F17, S+ n=42 Participants Antibody DEN-4, Group F17, Pre-vaccination status = S+	DEN-4, F17, Total n=127 Participants Antibody DEN-4, Group F17, Pre-vaccination status = Total	DEN-4, F19, S- n=61 Participants Antibody DEN-4, Group F19, Pre-vaccination status = S-	DEN-4, F19, S+ n=49 Participants Antibody DEN-4, Group F19, Pre-vaccination status = S+	DEN-4, F19, Total n=110 Participants Antibody DEN-4, Group F19, Pre-vaccination status = Total	DEN-4, Placebo, S- n=79 Participants Antibody DEN-4, Placebo group, Pre-vaccination status = S-	DEN-4, Placebo, S+ n=45 Participants Antibody DEN-4, Placebo group, Pre-vaccination status = S+	DEN-4, Placebo, Total n=124 Participants Antibody DEN-4, Placebo group, Pre-vaccination status = Total
Vaccine Response to DEN Antibody at Post Dose 1, Month 3	20.2 % of subjects Interval 12.3 to 30.4	54.1 % of subjects Interval 36.9 to 70.5	30.6 % of subjects Interval 22.5 to 39.6	30.2 % of subjects Interval 19.2 to 43.0	73.7 % of subjects Interval 56.9 to 86.6	46.5 % of subjects Interval 36.5 to 56.7	7.8 % of subjects Interval 2.9 to 16.2	7.0 % of subjects Interval 1.5 to 19.1	7.5 % of subjects Interval 3.5 to 13.8	25.9 % of subjects Interval 17.0 to 36.5	63.6 % of subjects Interval 45.1 to 79.6	36.4 % of subjects Interval 27.8 to 45.8	46.0 % of subjects Interval 33.4 to 59.1	64.4 % of subjects Interval 48.8 to 78.1	53.7 % of subjects Interval 43.8 to 63.3	3.9 % of subjects Interval 0.8 to 11.1	14.0 % of subjects Interval 5.3 to 27.9	7.6 % of subjects Interval 3.5 to 13.9	15.3 % of subjects Interval 8.4 to 24.7	61.1 % of subjects Interval 43.5 to 76.9	28.9 % of subjects Interval 21.0 to 37.9	28.8 % of subjects Interval 18.3 to 41.3	62.2 % of subjects Interval 46.5 to 76.2	42.3 % of subjects Interval 33.0 to 52.1	6.2 % of subjects Interval 2.0 to 13.8	5.1 % of subjects Interval 0.6 to 17.3	5.8 % of subjects Interval 2.4 to 11.6	38.8 % of subjects Interval 28.4 to 50.0	52.4 % of subjects Interval 36.4 to 68.0	43.3 % of subjects Interval 34.5 to 52.4	27.9 % of subjects Interval 17.1 to 40.8	65.3 % of subjects Interval 50.4 to 78.3	44.5 % of subjects Interval 35.1 to 54.3	7.6 % of subjects Interval 2.8 to 15.8	11.1 % of subjects Interval 3.7 to 24.1	8.9 % of subjects Interval 4.5 to 15.3

SECONDARY outcome

Timeframe: at month 7, post dose 2

Vaccine response for DEN-1, DEN2, DEN-3, DEN-4 antibody at post dose 2, month 7

Outcome measures

Outcome measures
Measure	T-DEN-Post-Transfection F17 n=83 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=35 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=118 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	After 31-Day Post Vaccination Period: F17 n=61 Participants Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post Vaccination Period: F19 n=37 Participants Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	After 31-Day Post-Vaccination Period: Placebo n=98 Participants Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months	F19 PI (M6) n=74 Participants Post-Transfection F-19 Post-dose 1, month 6	F19 PII (M7) n=43 Participants Post-Transfection F-19 Post-dose 2, month 7	Placebo: Pre-vaccination n=117 Participants Pre-vaccination (blood sample taken before dose 1)	Placebo: PI (M3) n=84 Participants Placebo control Post-dose 1, month 3	Placebo: PI (M6) n=32 Participants Placebo control Post-dose 1, month 6	Placebo: PII (M7) n=116 Participants Placebo control Post-dose 2, month 7	DEN-2, F19, S- n=62 Participants Antibody DEN-2, Group F19, Pre-vaccination status = S-	DEN-2, F19, S+ n=42 Participants Antibody DEN-2, Group F19, Pre-vaccination status = S+	DEN-2, F19, Total n=104 Participants Antibody DEN-2, Group F19, Pre-vaccination status = Total	DEN-2, Placebo, S- n=73 Participants Antibody DEN-2, Placebo group, Pre-vaccination status = S-	DEN-2, Placebo, S+ n=43 Participants Antibody DEN-2, Placebo group, Pre-vaccination status = S+	DEN-2, Placebo, Total n=116 Participants Antibody DEN-2, Placebo group, Pre-vaccination status = Total	DEN-3, F17, S- n=84 Participants Antibody DEN-3, Group F17, Pre-vaccination status = S-	DEN-3, F17, S+ n=34 Participants Antibody DEN-3, Group F17, Pre-vaccination status = S+	DEN-3, F17, Total n=118 Participants Antibody DEN-3, Group F17, Pre-vaccination status = Total	DEN-3, F19, S- n=64 Participants Antibody DEN-3, Group F19, Pre-vaccination status = S-	DEN-3, F19, S+ n=43 Participants Antibody DEN-3, Group F19, Pre-vaccination status = S+	DEN-3, F19, Total n=107 Participants Antibody DEN-3, Group F19, Pre-vaccination status = Total	DEN-3, Placebo, S- n=78 Participants Antibody DEN-3, Placebo group, Pre-vaccination status = S-	DEN-3, Placebo, S+ n=39 Participants Antibody DEN-3, Placebo group, Pre-vaccination status = S+	DEN-3, Placebo, Total n=117 Participants Antibody DEN-3, Placebo group, Pre-vaccination status = Total	DEN-4, F17, S- n=84 Participants Antibody DEN-4, Group F17, Pre-vaccination status = S-	DEN-4, F17, S+ n=40 Participants Antibody DEN-4, Group F17, Pre-vaccination status = S+	DEN-4, F17, Total n=124 Participants Antibody DEN-4, Group F17, Pre-vaccination status = Total	DEN-4, F19, S- n=60 Participants Antibody DEN-4, Group F19, Pre-vaccination status = S-	DEN-4, F19, S+ n=48 Participants Antibody DEN-4, Group F19, Pre-vaccination status = S+	DEN-4, F19, Total n=108 Participants Antibody DEN-4, Group F19, Pre-vaccination status = Total	DEN-4, Placebo, S- n=76 Participants Antibody DEN-4, Placebo group, Pre-vaccination status = S-	DEN-4, Placebo, S+ n=45 Participants Antibody DEN-4, Placebo group, Pre-vaccination status = S+	DEN-4, Placebo, Total n=121 Participants Antibody DEN-4, Placebo group, Pre-vaccination status = Total
Vaccine Response to DEN Antibody at Post Dose 2, Month 7	95.2 % of subjects Interval 88.1 to 98.7	60.0 % of subjects Interval 42.1 to 76.1	84.7 % of subjects Interval 77.0 to 90.7	83.6 % of subjects Interval 71.9 to 91.8	75.7 % of subjects Interval 58.8 to 88.2	80.6 % of subjects Interval 71.4 to 87.9	6.8 % of subjects Interval 2.2 to 15.1	11.6 % of subjects Interval 3.9 to 25.1	8.5 % of subjects Interval 4.2 to 15.2	89.3 % of subjects Interval 80.6 to 95.0	71.9 % of subjects Interval 53.3 to 86.3	84.5 % of subjects Interval 76.6 to 90.5	93.5 % of subjects Interval 84.3 to 98.2	64.3 % of subjects Interval 48.0 to 78.4	81.7 % of subjects Interval 72.9 to 88.6	4.1 % of subjects Interval 0.9 to 11.5	14.0 % of subjects Interval 5.3 to 27.9	7.8 % of subjects Interval 3.6 to 14.2	92.9 % of subjects Interval 85.1 to 97.3	47.1 % of subjects Interval 29.8 to 64.9	79.7 % of subjects Interval 71.3 to 86.5	79.7 % of subjects Interval 67.8 to 88.7	48.8 % of subjects Interval 33.3 to 64.5	67.3 % of subjects Interval 57.5 to 76.0	9.0 % of subjects Interval 3.7 to 17.6	15.4 % of subjects Interval 5.9 to 30.5	11.1 % of subjects Interval 6.1 to 18.3	97.6 % of subjects Interval 91.7 to 99.7	57.5 % of subjects Interval 40.9 to 73.0	84.7 % of subjects Interval 77.1 to 90.5	86.7 % of subjects Interval 75.4 to 94.1	68.8 % of subjects Interval 53.7 to 81.3	78.7 % of subjects Interval 69.8 to 86.0	7.9 % of subjects Interval 3.0 to 16.4	6.7 % of subjects Interval 1.4 to 18.3	7.4 % of subjects Interval 3.5 to 13.7

Adverse Events

T-DEN-Post-Transfection F17

Serious events: 8 serious events

Other events: 90 other events

Deaths: 0 deaths

T-DEN-Post-Transfection F19

Serious events: 4 serious events

Other events: 93 other events

Deaths: 0 deaths

Placebo

Serious events: 11 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	T-DEN-Post-Transfection F17 n=211 participants at risk Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=212 participants at risk Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=213 participants at risk Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months
Infections and infestations Cellulitis (face)	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Cellulitis orbital	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Eye disorders Conjunctivitis	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Dengue fever	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Tonsillitis	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Gastrointestinal disorders Acute gastroenteritis	0.95% 2/211 • Number of events 2 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Sinusitis	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Upper respiratory tract infection	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Gastrointestinal disorders Acute viral gastroenteritis	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Gastrointestinal disorders Gastroenteritis	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Pneumonia	0.00% 0/211 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	0.94% 2/213 • Number of events 2 • 12 months
Metabolism and nutrition disorders Dehydration	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Respiratory, thoracic and mediastinal disorders Tonsillitis	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Presumptive viral syndrome	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Acute bronchitis	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Bronchial asthma	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Bronchitis	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Gastrointestinal disorders Diarrhea	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Viral infection	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Renal and urinary disorders Ureteral calculus	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Renal and urinary disorders Renal failure acute	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure	T-DEN-Post-Transfection F17 n=211 participants at risk Post-Transfection F17, full dose T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	T-DEN-Post-Transfection F19 n=212 participants at risk Post-Transfection F19, full dose T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months	Placebo n=213 participants at risk Control Placebo: Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months
General disorders Pain	14.2% 30/211 • Number of events 30 • 12 months	12.3% 26/212 • Number of events 26 • 12 months	8.0% 17/213 • Number of events 17 • 12 months
Skin and subcutaneous tissue disorders Redness	7.6% 16/211 • Number of events 16 • 12 months	3.3% 7/212 • Number of events 7 • 12 months	3.8% 8/213 • Number of events 8 • 12 months
General disorders Swelling	3.8% 8/211 • Number of events 8 • 12 months	3.3% 7/212 • Number of events 7 • 12 months	2.8% 6/213 • Number of events 6 • 12 months
Metabolism and nutrition disorders Swelling	4.7% 10/211 • Number of events 10 • 12 months	3.3% 7/212 • Number of events 7 • 12 months	1.9% 4/213 • Number of events 4 • 12 months
Gastrointestinal disorders Abdominal pain	0.95% 2/211 • Number of events 2 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
General disorders Fatigue	5.2% 11/211 • Number of events 11 • 12 months	3.3% 7/212 • Number of events 7 • 12 months	6.6% 14/213 • Number of events 14 • 12 months
General disorders Fever (axillary)	24.2% 51/211 • Number of events 51 • 12 months	21.7% 46/212 • Number of events 46 • 12 months	16.9% 36/213 • Number of events 36 • 12 months
Nervous system disorders Headache	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.94% 2/213 • Number of events 2 • 12 months
Skin and subcutaneous tissue disorders Pruritus	2.4% 5/211 • Number of events 5 • 12 months	3.8% 8/212 • Number of events 8 • 12 months	2.8% 6/213 • Number of events 6 • 12 months
Skin and subcutaneous tissue disorders Rash	0.00% 0/211 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	0.00% 0/213 • 12 months
Gastrointestinal disorders Vomiting	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Ear and labyrinth disorders Ear congestion	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Ear and labyrinth disorders Ear pain	0.47% 1/211 • Number of events 1 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.94% 2/213 • Number of events 2 • 12 months
Infections and infestations Conjunctivitis	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Eye disorders Photophobia	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Gastrointestinal disorders Abdominal pain (upper)	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Gastrointestinal disorders Constipation	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Gastrointestinal disorders Diarrhea	0.47% 1/211 • Number of events 1 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	0.94% 2/213 • Number of events 2 • 12 months
Gastrointestinal disorders Enteritis	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
General disorders Injection site reaction	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
General disorders Irritability	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
General disorders Pyrexia	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
General disorders Thirst	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Immune system disorders Food allergy	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Abscess	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Bronchiolitis	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Bronchitis	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Croup infectious	0.00% 0/211 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Ear infection	0.00% 0/211 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	0.94% 2/213 • Number of events 2 • 12 months
Gastrointestinal disorders Gastroenteritis	0.47% 1/211 • Number of events 1 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	0.00% 0/213 • 12 months
Gastrointestinal disorders Gastroenteritis viral	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Genital candidiasis	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Impetigo	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Infected bites	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Infection parasitic	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Nasopharyngitis	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	1.4% 3/213 • Number of events 3 • 12 months
Infections and infestations Otitis externa	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Otitis media	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Otitis media acute	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Parasitic gastroenteritis	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Pharyngitis	1.4% 3/211 • Number of events 3 • 12 months	1.4% 3/212 • Number of events 3 • 12 months	2.3% 5/213 • Number of events 5 • 12 months
Infections and infestations Pneumonia	0.00% 0/211 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Rhinitis	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Sinusitis	0.47% 1/211 • Number of events 1 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	1.4% 3/213 • Number of events 3 • 12 months
Infections and infestations Subcutaneous abscess	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Tonsillitis	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.94% 2/213 • Number of events 2 • 12 months
Infections and infestations Upper respiratory tract infection	3.3% 7/211 • Number of events 7 • 12 months	3.8% 8/212 • Number of events 8 • 12 months	3.3% 7/213 • Number of events 7 • 12 months
Infections and infestations Urinary tract infection	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Viral infection	0.95% 2/211 • Number of events 2 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Arthropod bite	0.47% 1/211 • Number of events 1 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Bruns first degree	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Injury, poisoning and procedural complications Excoriation	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Head injury	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Injury, poisoning and procedural complications Limb injury	0.47% 1/211 • Number of events 1 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Injury, poisoning and procedural complications Scratch	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Injury, poisoning and procedural complications Skin laceration	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Injury, poisoning and procedural complications Tooth injury	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Metabolism and nutrition disorders Decreased appetite	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Muscle spasms	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Nervous system disorders Crying	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Nervous system disorders Psychomotor hyperactivity	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Psychiatric disorders Aggression	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Respiratory, thoracic and mediastinal disorders Asthma	0.47% 1/211 • Number of events 1 • 12 months	1.4% 3/212 • Number of events 3 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.47% 1/211 • Number of events 1 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.94% 2/213 • Number of events 2 • 12 months
Respiratory, thoracic and mediastinal disorders Cough	1.9% 4/211 • Number of events 4 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	0.00% 0/213 • 12 months
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.9% 4/211 • Number of events 4 • 12 months	1.9% 4/212 • Number of events 4 • 12 months	0.94% 2/213 • Number of events 2 • 12 months
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.4% 5/211 • Number of events 5 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	0.94% 2/213 • Number of events 2 • 12 months
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.95% 2/211 • Number of events 2 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	1.4% 3/213 • Number of events 3 • 12 months
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Skin and subcutaneous tissue disorders Dermatitis allergic	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Skin and subcutaneous tissue disorders Dermatitis atopic	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Skin and subcutaneous tissue disorders Rash generalized	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Skin and subcutaneous tissue disorders Urticaria	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Cardiac disorders Tachycardia	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Conuunctivitis	0.95% 2/211 • Number of events 2 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Conjunctivitis allergic	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Eye disorders Eye pain	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Eye disorders Ocular hyperaemia	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Gastrointestinal disorders Anal pruritus	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Gastrointestinal disorders Dry mouth	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Gastrointestinal disorders Dyspepsia	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Gastrointestinal disorders Gastritis	0.47% 1/211 • Number of events 1 • 12 months	0.94% 2/212 • Number of events 2 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Gastrointestinal disorders Gastroesophageal reflux desease	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Gastrointestinal disorders Sensitivity of teeth	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Gastrointestinal disorders Tooth development disorder	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
General disorders Chills	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
General disorders Exercise tolerance decreased	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
General disorders Influenza like symptoms	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
General disorders Injection site haematoma	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
General disorders Injection site pruritus	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Immune system disorders Drug hypersensitivity	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Immune system disorders Hypersensitivity	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Immune system disorders Seasonal allergy	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Acute sinusitis	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Cellulitis	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Enterobiasis	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Fungal skin infection	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Infections and infestations Gingival abscess	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Influenza	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Tinea versicolour	0.47% 1/211 • Number of events 1 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Infections and infestations Viral pharyngitis	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Joint injury	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Joint sprain	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Back pain	1.9% 4/211 • Number of events 4 • 12 months	1.4% 3/212 • Number of events 3 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Costochondritis	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	1.9% 4/213 • Number of events 4 • 12 months
Nervous system disorders Dizziness	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.94% 2/213 • Number of events 2 • 12 months
Nervous system disorders Dysgeusia	0.95% 2/211 • Number of events 2 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	1.4% 3/213 • Number of events 3 • 12 months
Nervous system disorders Paraesthesia	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Nervous system disorders Insomnia	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Renal and urinary disorders Bladder pain	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Reproductive system and breast disorders Breast tenderness	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Reproductive system and breast disorders Ovarian disorder	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Reproductive system and breast disorders Penis disorder	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Skin and subcutaneous tissue disorders Dermititis allergic	0.95% 2/211 • Number of events 2 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/211 • 12 months	0.00% 0/212 • 12 months	0.47% 1/213 • Number of events 1 • 12 months
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/211 • 12 months	0.47% 1/212 • Number of events 1 • 12 months	0.00% 0/213 • 12 months
Skin and subcutaneous tissue disorders Rash papular	0.47% 1/211 • Number of events 1 • 12 months	0.00% 0/212 • 12 months	0.00% 0/213 • 12 months

Additional Information

Faina Rose, PhD

GSK

Phone: 610-664-8986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place