Trial Outcomes & Findings for Immunogenicity and Safety of a Tetravalent Dengue Vaccine Booster Injection in Subjects Who Previously Completed a 3-dose Schedule (NCT NCT02824198)

NCT ID: NCT02824198

Last Updated: 2022-03-24

Results Overview

GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the plaque reduction neutralization test (PRNT).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 118 participants
• Primary outcome timeframe: 28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63
• Results posted on: 2022-03-24

Participant Flow

Study participants were enrolled from 01 July 2016 to 18 February 2017 at 3 sites in Singapore.

A total of 118 participants who received 3 doses of CYD dengue vaccine in study CYD28 (NCT00880893) were enrolled and randomized in this study (CYD63).

Participant milestones

Measure	CYD Dengue Vaccine Booster Group Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).	Placebo Group Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Study STARTED	89	29
Overall Study COMPLETED	74	26
Overall Study NOT COMPLETED	15	3

Reasons for withdrawal

Measure	CYD Dengue Vaccine Booster Group Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).	Placebo Group Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Study Non-compliance with the protocol	5	1
Overall Study Lost to Follow-up	5	2
Overall Study Withdrawal by Subject	5	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	CYD Dengue Vaccine Booster Group n=89 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).	Placebo Group n=29 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).	Total n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	11 Participants n=89 Participants	0 Participants n=29 Participants	11 Participants n=118 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=89 Participants	29 Participants n=29 Participants	107 Participants n=118 Participants
Age, Categorical >=65 years	0 Participants n=89 Participants	0 Participants n=29 Participants	0 Participants n=118 Participants
Age, Continuous	28.1 years STANDARD_DEVIATION 11.18 • n=89 Participants	28.2 years STANDARD_DEVIATION 9.18 • n=29 Participants	28.2 years STANDARD_DEVIATION 10.69 • n=118 Participants
Sex: Female, Male Female	43 Participants n=89 Participants	15 Participants n=29 Participants	58 Participants n=118 Participants
Sex: Female, Male Male	46 Participants n=89 Participants	14 Participants n=29 Participants	60 Participants n=118 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63

Population: Analysis was performed on Per-Protocol Analysis Set which included all participants who had no protocol deviations from the present study (CYD63). Here, 'number analyzed' = participants with available data for each specified category.

GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the plaque reduction neutralization test (PRNT).

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=75 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 1	20.3 titers (1/dilution) Interval 13.9 to 29.5	37.7 titers (1/dilution) Interval 26.4 to 53.7
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 2	85.6 titers (1/dilution) Interval 55.7 to 132.0	56.2 titers (1/dilution) Interval 38.5 to 82.1
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 3	102 titers (1/dilution) Interval 78.4 to 133.0	105 titers (1/dilution) Interval 77.4 to 142.0
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 4	92.8 titers (1/dilution) Interval 72.5 to 119.0	123 titers (1/dilution) Interval 93.8 to 161.0

SECONDARY outcome

Timeframe: Pre-booster injection (Day 0) and 28 days post-booster injection

Population: Analysis was performed on Per-Protocol Analysis Set.

GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=28 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: Pre-booster Inj.	13.5 titers (1/dilution) Interval 9.31 to 19.6	16.7 titers (1/dilution) Interval 7.73 to 36.1
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 28 days Post-booster Inj.	37.7 titers (1/dilution) Interval 26.4 to 53.7	18.1 titers (1/dilution) Interval 8.61 to 38.1
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: Pre-booster Inj.	18.4 titers (1/dilution) Interval 12.1 to 28.0	23.2 titers (1/dilution) Interval 9.97 to 53.9
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 28 days Post-booster Inj.	56.2 titers (1/dilution) Interval 38.5 to 82.1	21.5 titers (1/dilution) Interval 9.61 to 48.1
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: Pre-booster Inj.	22.4 titers (1/dilution) Interval 15.6 to 32.0	27.4 titers (1/dilution) Interval 14.8 to 51.0
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: 28 days Post-booster Inj.	105 titers (1/dilution) Interval 77.4 to 142.0	24.1 titers (1/dilution) Interval 13.6 to 42.6
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: Pre-booster Inj.	28.0 titers (1/dilution) Interval 20.4 to 38.5	44.9 titers (1/dilution) Interval 28.3 to 71.3
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 28 days Post-booster Inj.	123 titers (1/dilution) Interval 93.8 to 161.0	39.8 titers (1/dilution) Interval 23.9 to 66.3

SECONDARY outcome

Timeframe: Pre-booster injection (Day 0) and 28 days post-booster injection

Population: Analysis was performed on Per-Protocol Analysis Set.

GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection.

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=28 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1	1.74 ratio Interval 1.33 to 2.28	0.676 ratio Interval 0.525 to 0.871
GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2	2.04 ratio Interval 1.54 to 2.69	0.624 ratio Interval 0.523 to 0.745
GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3	3.52 ratio Interval 2.58 to 4.82	0.669 ratio Interval 0.513 to 0.873
GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4	3.58 ratio Interval 2.61 to 4.9	0.822 ratio Interval 0.64 to 1.06

SECONDARY outcome

Timeframe: Pre-booster injection (Day 0) and 28 days post-booster injection

Population: Analysis was performed on Per-Protocol Analysis Set.

Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution).

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=28 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: Pre-booster Inj.	70.7 percentage of participants	89.3 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: Pre-booster Inj.	32.0 percentage of participants	32.1 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 28 days Post-booster Inj.	74.7 percentage of participants	35.7 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: Pre-booster Inj.	41.3 percentage of participants	42.9 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 28 days Post-booster Inj.	81.3 percentage of participants	42.9 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: Pre-booster Inj.	58.7 percentage of participants	60.7 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: 28 days Post-booster Inj.	96.0 percentage of participants	67.9 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 28 days Post-booster Inj.	97.3 percentage of participants	82.1 percentage of participants

SECONDARY outcome

Timeframe: 28 days post-booster injection

Population: Analysis was performed on Per-Protocol Analysis Set.

Seroconversion rates for each serotypes were defined as the percentages of participants with either a pre-booster titer < 10 (1/dilution) and a post-booster titer >= 40 (1/dilution), or a pre-booster titer >=10 (1/dilution) and a >= 4-fold increase in post-booster titer as determined by PRNT.

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=28 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1	29.3 percentage of participants	3.6 percentage of participants
Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2	29.3 percentage of participants	0.0 percentage of participants
Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3	44.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4	38.7 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 28 days post-dose 3 in CYD28 and pre-booster injection (Day 0) in CYD 63

Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.

GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT.

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=28 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 Dengue Virus Serotype 1: 28 days Post-dose 3	20.3 titers (1/dilution) Interval 13.9 to 29.5	26.8 titers (1/dilution) Interval 12.4 to 57.7
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 Dengue Virus Serotype 1: Pre-booster Inj.	13.5 titers (1/dilution) Interval 9.31 to 19.6	16.7 titers (1/dilution) Interval 7.73 to 36.1
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 Dengue Virus Serotype 2: 28 days Post-dose 3	85.6 titers (1/dilution) Interval 55.7 to 132.0	65.4 titers (1/dilution) Interval 28.3 to 151.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 Dengue Virus Serotype 2: Pre-booster Inj.	18.4 titers (1/dilution) Interval 12.1 to 28.0	23.2 titers (1/dilution) Interval 9.97 to 53.9
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 Dengue Virus Serotype 3: 28 days Post-dose 3	102 titers (1/dilution) Interval 78.4 to 133.0	107 titers (1/dilution) Interval 63.6 to 179.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 Dengue Virus Serotype 3: Pre-booster Inj.	22.4 titers (1/dilution) Interval 15.6 to 32.0	27.4 titers (1/dilution) Interval 14.8 to 51.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 Dengue Virus Serotype 4: 28 days Post-dose 3	92.8 titers (1/dilution) Interval 72.5 to 119.0	86.5 titers (1/dilution) Interval 51.0 to 147.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 Dengue Virus Serotype 4: Pre-booster Inj.	28.0 titers (1/dilution) Interval 20.4 to 38.5	44.9 titers (1/dilution) Interval 28.3 to 71.3

SECONDARY outcome

Timeframe: 28 days post-dose 3 in CYD28 and pre-booster injection (Day 0) in CYD63

Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed'=participants with available data for each specified category.

GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT. GMTRs were calculated as the ratio of GMTs post-dose 3 in CYD28 and pre-booster injection in CYD63.

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=28 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1	0.487 ratio Interval 0.39 to 0.609	0.441 ratio Interval 0.316 to 0.617
GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2	0.199 ratio Interval 0.16 to 0.248	0.313 ratio Interval 0.224 to 0.437
GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3	0.207 ratio Interval 0.163 to 0.262	0.267 ratio Interval 0.171 to 0.416
GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4	0.291 ratio Interval 0.217 to 0.391	0.474 ratio Interval 0.343 to 0.656

SECONDARY outcome

Timeframe: 28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63

Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.

Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution).

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=28 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 28 days Post-dose 3	52.7 percentage of participants	50.0 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 28 days Post-booster Inj.	74.7 percentage of participants	35.7 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 28 days Post-dose 3	89.0 percentage of participants	74.1 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 28 days Post-booster Inj.	81.3 percentage of participants	42.9 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: 28 days Post-dose 3	97.2 percentage of participants	96.3 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: 28 days Post-booster Inj.	96.0 percentage of participants	67.9 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 28 days Post-dose 3	95.7 percentage of participants	88.5 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 28 days Post-booster Inj.	97.3 percentage of participants	82.1 percentage of participants

SECONDARY outcome

Timeframe: 6 months, 12 months, and 24 months post-booster injection

Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.

GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=28 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1:6 months Post-booster Inj.	25.1 titers (1/dilution) Interval 17.4 to 36.4	14.3 titers (1/dilution) Interval 7.42 to 27.6
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype1:12 months Post-booster Inj.	20.9 titers (1/dilution) Interval 14.0 to 31.1	14.6 titers (1/dilution) Interval 7.55 to 28.3
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype1:24 months Post-booster Inj.	14.4 titers (1/dilution) Interval 9.88 to 21.0	13.6 titers (1/dilution) Interval 7.14 to 25.7
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2:6 months Post-booster Inj.	44.3 titers (1/dilution) Interval 29.0 to 67.7	20.4 titers (1/dilution) Interval 9.07 to 45.9
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype2:12 months Post-booster Inj.	39.3 titers (1/dilution) Interval 25.3 to 61.2	22.1 titers (1/dilution) Interval 9.95 to 49.1
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype2:24 months Post-booster Inj.	41.6 titers (1/dilution) Interval 25.8 to 67.2	21.7 titers (1/dilution) Interval 9.49 to 49.8
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3:6 months Post-booster Inj.	65.1 titers (1/dilution) Interval 47.3 to 89.5	26.7 titers (1/dilution) Interval 15.3 to 46.7
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype3:12 months Post-booster Inj.	54.8 titers (1/dilution) Interval 40.1 to 74.9	20.6 titers (1/dilution) Interval 11.8 to 36.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype3:24 months Post-booster Inj.	36.5 titers (1/dilution) Interval 25.6 to 51.8	16.8 titers (1/dilution) Interval 9.36 to 30.2
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4:6 months Post-booster Inj.	75.6 titers (1/dilution) Interval 58.8 to 97.2	34.6 titers (1/dilution) Interval 20.5 to 58.5
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype4:12 months Post-booster Inj.	61.9 titers (1/dilution) Interval 47.2 to 81.2	33.1 titers (1/dilution) Interval 21.0 to 52.2
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype4:24 months Post-booster Inj.	50.1 titers (1/dilution) Interval 38.4 to 65.4	24.5 titers (1/dilution) Interval 14.0 to 42.8

SECONDARY outcome

Timeframe: Pre-booster injection (Day 0) and 6 months, 12 months, 24 months post-booster injection

Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.

GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection.

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=28 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 6 months/Day 0	1.60 ratio Interval 1.25 to 2.06	0.634 ratio Interval 0.525 to 0.766
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 12 months/Day 0	1.42 ratio Interval 1.11 to 1.8	0.687 ratio Interval 0.564 to 0.838
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 6 months/Day 0	1.19 ratio Interval 0.953 to 1.51	0.646 ratio Interval 0.544 to 0.767
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 12 months/Day 0	0.983 ratio Interval 0.775 to 1.25	0.660 ratio Interval 0.516 to 0.845
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 24 months/Day 0	0.658 ratio Interval 0.528 to 0.818	0.594 ratio Interval 0.5 to 0.705
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 24 months/Day 0	1.43 ratio Interval 1.12 to 1.84	0.646 ratio Interval 0.491 to 0.85
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: 6 months/Day 0	2.14 ratio Interval 1.6 to 2.85	0.797 ratio Interval 0.606 to 1.05
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: 12 months/Day 0	1.76 ratio Interval 1.35 to 2.3	0.614 ratio Interval 0.455 to 0.829
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: 24 months/Day 0	1.11 ratio Interval 0.876 to 1.42	0.479 ratio Interval 0.357 to 0.642
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 6 months/Day 0	2.17 ratio Interval 1.67 to 2.82	0.743 ratio Interval 0.53 to 1.04
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 12 months/Day 0	1.70 ratio Interval 1.28 to 2.27	0.710 ratio Interval 0.556 to 0.906
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 24 months/Day 0	1.35 ratio Interval 1.04 to 1.75	0.529 ratio Interval 0.384 to 0.73

SECONDARY outcome

Timeframe: 6 months, 12 months, and 24 months post-booster injection

Population: Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.

Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution).

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=75 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=28 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2:6 months Post-booster Inj.	72.2 percentage of participants	40.7 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype2:24 months Post-booster Inj.	65.2 percentage of participants	42.3 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype3:12 months Post-booster Inj.	89.9 percentage of participants	63.0 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype3:24 months Post-booster Inj.	76.9 percentage of participants	50.0 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1:6 months Post-booster Inj.	59.7 percentage of participants	33.3 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype1:12 months Post-booster Inj.	49.3 percentage of participants	33.3 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype1:24 months Post-booster Inj.	37.9 percentage of participants	34.6 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype2:12 months Post-booster Inj.	66.7 percentage of participants	44.4 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3:6 months Post-booster Inj.	88.9 percentage of participants	70.4 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4:6 months Post-booster Inj.	95.8 percentage of participants	77.8 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype4:12 months Post-booster Inj.	91.3 percentage of participants	85.2 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype4:24 months Post-booster Inj.	89.4 percentage of participants	65.4 percentage of participants

SECONDARY outcome

Timeframe: Within 7 days after booster injection

Population: Analysis was performed on Safety Analysis Set which included all participants who received either CYD dengue vaccine or placebo. Here, 'number analyzed' = participants with available data for specified category.

Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 injection site reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 millimeter.

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=89 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=29 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Injection-site Erythema: Any	1 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Injection-site Pain: Any	29 Participants	7 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Injection-site Pain: Grade 3	1 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Injection-site Erythema: Grade 3	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Injection-site Swelling: Any	0 Participants	0 Participants
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Injection-site Swelling: Grade 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 14 days after booster injection

Population: Analysis was performed on Safety Analysis Set. Here, 'number analyzed' = participants with available data for specified category.

Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >=39 degree Celsius; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity.

Outcome measures

Measure	CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 n=89 Participants Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).	CYD Dengue Vaccine Booster Group: Post Booster Dose n=29 Participants Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Fever: Grade 3	0 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Headache: Any Grade	23 Participants	3 Participants
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Headache: Grade 3	0 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Myalgia: Any Grade	21 Participants	7 Participants
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Myalgia: Grade 3	0 Participants	1 Participants
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Asthenia: Any Grade	15 Participants	4 Participants
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Asthenia: Grade 3	0 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Fever: Any Grade	2 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Malaise: Any Grade	11 Participants	3 Participants
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo Malaise: Grade 3	0 Participants	1 Participants

Adverse Events

CYD Dengue Vaccine Booster Group

Serious events: 5 serious events

Other events: 47 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	CYD Dengue Vaccine Booster Group n=89 participants at risk Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).	Placebo Group n=29 participants at risk Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Infections and infestations Influenza	1.1% 1/89 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	0.00% 0/29 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
Injury, poisoning and procedural complications Road Traffic Accident	1.1% 1/89 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	0.00% 0/29 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
Pregnancy, puerperium and perinatal conditions Pre-Eclampsia	1.1% 1/89 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	0.00% 0/29 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
Reproductive system and breast disorders Ovarian Cyst	1.1% 1/89 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	0.00% 0/29 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
Reproductive system and breast disorders Pelvic Pain	1.1% 1/89 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	0.00% 0/29 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.

Other adverse events

Measure	CYD Dengue Vaccine Booster Group n=89 participants at risk Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).	Placebo Group n=29 participants at risk Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
General disorders Asthenia	16.9% 15/89 • Number of events 15 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	13.8% 4/29 • Number of events 4 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
General disorders Injection Site Pain	32.6% 29/89 • Number of events 29 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	24.1% 7/29 • Number of events 7 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
General disorders Malaise	12.4% 11/89 • Number of events 11 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	10.3% 3/29 • Number of events 3 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
Infections and infestations Upper Respiratory Tract Infection	6.7% 6/89 • Number of events 7 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	3.4% 1/29 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
Musculoskeletal and connective tissue disorders Myalgia	23.6% 21/89 • Number of events 21 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	24.1% 7/29 • Number of events 7 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
Nervous system disorders Headache	25.8% 23/89 • Number of events 23 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.	13.8% 4/29 • Number of events 4 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 24 months after booster injection). Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.

Additional Information

Medical Director

Sanofi Pasteur

Phone: 800-633-1610

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Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
• Publication restrictions are in place

Restriction type: OTHER