Trial Outcomes & Findings for Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule (NCT NCT02623725)

Results Overview

Geometric Mean Titers (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

251 participants

Primary outcome timeframe

28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64

Results posted on

2022-03-24

Participant Flow

Study participants were enrolled from 14 April 2016 to 19 October 2016 at 5 sites, one each in Brazil, Colombia, Honduras, Mexico, and Puerto Rico.

A total of 251 participants who received 3 doses of CYD dengue vaccine in previous studies CYD13 (NCT00993447) and CYD30 (NCT01187433) were enrolled and randomized in this study (CYD64).

Participant milestones

Participant milestones
Measure	CYD Dengue Vaccine Booster Group Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).	Placebo Group Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Study STARTED	187	64
Overall Study COMPLETED	171	58
Overall Study NOT COMPLETED	16	6

Reasons for withdrawal

Reasons for withdrawal
Measure	CYD Dengue Vaccine Booster Group Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).	Placebo Group Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Study Non compliance with protocol	9	3
Overall Study Serious adverse event	0	2
Overall Study Withdrawal by Subject	7	1

Baseline Characteristics

Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CYD Dengue Vaccine Booster Group n=187 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).	Placebo Group n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).	Total n=251 Participants Total of all reporting groups
Age, Categorical <=18 years	63 Participants n=5 Participants	19 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	124 Participants n=5 Participants	45 Participants n=7 Participants	169 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	19.2 years STANDARD_DEVIATION 2.14 • n=5 Participants	19.0 years STANDARD_DEVIATION 1.99 • n=7 Participants	19.1 years STANDARD_DEVIATION 2.10 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	27 Participants n=7 Participants	116 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	37 Participants n=7 Participants	135 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64

Population: Analysis was performed on Per-Protocol Analysis Set which included all participants who had no protocol deviations from the present study (CYD64). Here, 'number analyzed' = participants with available data for each specified category.

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

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 1	316 titers (1/dilution) Interval 233.0 to 428.0	560 titers (1/dilution) Interval 421.0 to 744.0
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 2	356 titers (1/dilution) Interval 275.0 to 462.0	657 titers (1/dilution) Interval 520.0 to 830.0
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 3	640 titers (1/dilution) Interval 516.0 to 794.0	671 titers (1/dilution) Interval 535.0 to 843.0
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 4	243 titers (1/dilution) Interval 195.0 to 303.0	344 titers (1/dilution) Interval 279.0 to 424.0

SECONDARY outcome

Timeframe: 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64

Population: Analysis was performed on Full analysis set which included all participants who received either CYD Dengue Vaccine or placebo and had blood sample drawn and valid post-injection serology results. 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

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=184 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=184 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 1	304 titers (1/dilution) Interval 225.0 to 409.0	538 titers (1/dilution) Interval 406.0 to 714.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 2	338 titers (1/dilution) Interval 261.0 to 436.0	648 titers (1/dilution) Interval 515.0 to 817.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 3	617 titers (1/dilution) Interval 499.0 to 762.0	660 titers (1/dilution) Interval 528.0 to 827.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group Dengue Virus Serotype 4	241 titers (1/dilution) Interval 195.0 to 298.0	341 titers (1/dilution) Interval 278.0 to 418.0

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

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
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.	325 titers (1/dilution) Interval 233.0 to 452.0	349 titers (1/dilution) Interval 201.0 to 607.0
GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 28 days Post-booster Inj.	560 titers (1/dilution) Interval 421.0 to 744.0	297 titers (1/dilution) Interval 162.0 to 547.0
GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: Pre-booster Inj.	360 titers (1/dilution) Interval 267.0 to 484.0	323 titers (1/dilution) Interval 195.0 to 535.0
GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 28 days Post-booster Inj.	657 titers (1/dilution) Interval 520.0 to 830.0	354 titers (1/dilution) Interval 205.0 to 610.0
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: Pre-booster Inj.	357 titers (1/dilution) Interval 269.0 to 472.0	442 titers (1/dilution) Interval 270.0 to 724.0
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.	671 titers (1/dilution) Interval 535.0 to 843.0	432 titers (1/dilution) Interval 266.0 to 700.0
GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: Pre-booster Inj.	162 titers (1/dilution) Interval 134.0 to 195.0	161 titers (1/dilution) Interval 108.0 to 242.0
GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 28 days Post-booster Inj.	344 titers (1/dilution) Interval 279.0 to 424.0	161 titers (1/dilution) Interval 110.0 to 237.0

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. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1	1.59 ratio Interval 1.33 to 1.9	0.798 ratio Interval 0.623 to 1.02
GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2	1.70 ratio Interval 1.43 to 2.03	1.03 ratio Interval 0.754 to 1.4
GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3	1.78 ratio Interval 1.47 to 2.16	0.946 ratio Interval 0.749 to 1.19
GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4	2.09 ratio Interval 1.65 to 2.63	0.946 ratio Interval 0.777 to 1.15

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 greater than or equal to (\>=)10 (1/dilution).

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
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.	88.1 percentage of participants	90.6 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.	96.0 percentage of participants	84.4 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.	89.8 percentage of participants	90.6 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.	98.9 percentage of participants	87.5 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.	92.1 percentage of participants	95.3 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 3: 28 days Post-booster Inj.	99.4 percentage of participants	95.3 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 4: Pre-booster Inj.	97.2 percentage of participants	92.2 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.	100.0 percentage of participants	93.8 percentage of participants

SECONDARY outcome

Timeframe: 28 days post-booster injection

Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.

Seroconversion for each serotype was defined as the percentage 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

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=184 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1	17.9 percentage of participants	3.1 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	20.1 percentage of participants	17.2 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	21.2 percentage of participants	4.7 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	20.7 percentage of participants	6.3 percentage of participants

SECONDARY outcome

Timeframe: 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64

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

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 28 days Post-dose 3	316 titers (1/dilution) Interval 233.0 to 428.0	232 titers (1/dilution) Interval 142.0 to 381.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: Pre-booster Inj.	325 titers (1/dilution) Interval 233.0 to 452.0	349 titers (1/dilution) Interval 201.0 to 607.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 28 days Post-dose 3	356 titers (1/dilution) Interval 275.0 to 462.0	303 titers (1/dilution) Interval 210.0 to 438.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: Pre-booster Inj.	360 titers (1/dilution) Interval 267.0 to 484.0	323 titers (1/dilution) Interval 195.0 to 535.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: 28 days Post-dose 3	640 titers (1/dilution) Interval 516.0 to 794.0	541 titers (1/dilution) Interval 372.0 to 785.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: Pre-booster Inj.	357 titers (1/dilution) Interval 269.0 to 472.0	442 titers (1/dilution) Interval 270.0 to 724.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 28 days Post-dose 3	243 titers (1/dilution) Interval 195.0 to 303.0	255 titers (1/dilution) Interval 192.0 to 340.0
GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: Pre-booster Inj.	162 titers (1/dilution) Interval 134.0 to 195.0	161 titers (1/dilution) Interval 108.0 to 242.0

SECONDARY outcome

Timeframe: 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64

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 pre-booster injection and post-dose injection.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1	0.952 ratio Interval 0.765 to 1.18	1.41 ratio Interval 0.927 to 2.14
GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2	0.986 ratio Interval 0.778 to 1.25	1.04 ratio Interval 0.662 to 1.65
GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3	0.536 ratio Interval 0.44 to 0.654	0.818 ratio Interval 0.574 to 1.16
GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4	0.618 ratio Interval 0.497 to 0.77	0.613 ratio Interval 0.427 to 0.881

SECONDARY outcome

Timeframe: 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64

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

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 28 days Post-dose 3	90.9 percentage of participants	90.6 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: 28 days Post-booster Inj.	96.0 percentage of participants	84.4 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 28 days Post-dose 3	95.4 percentage of participants	96.9 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: 28 days Post-booster Inj.	98.9 percentage of participants	87.5 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: 28 days Post-dose 3	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: 28 days Post-booster Inj.	99.4 percentage of participants	95.3 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 28 days Post-dose 3	92.0 percentage of participants	96.8 percentage of participants
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: 28 days Post-booster Inj.	100.0 percentage of participants	93.8 percentage of participants

SECONDARY outcome

Timeframe: 6 months,12 months, and 24 months post-booster injection in CYD64

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

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
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.	270 titers (1/dilution) Interval 205.0 to 356.0	185 titers (1/dilution) Interval 112.0 to 304.0
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.	241 titers (1/dilution) Interval 180.0 to 323.0	182 titers (1/dilution) Interval 112.0 to 297.0
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.	270 titers (1/dilution) Interval 205.0 to 356.0	192 titers (1/dilution) Interval 111.0 to 329.0
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.	442 titers (1/dilution) Interval 358.0 to 546.0	335 titers (1/dilution) Interval 217.0 to 515.0
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.	269 titers (1/dilution) Interval 217.0 to 335.0	225 titers (1/dilution) Interval 152.0 to 334.0
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.	246 titers (1/dilution) Interval 192.0 to 315.0	187 titers (1/dilution) Interval 126.0 to 279.0
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.	503 titers (1/dilution) Interval 397.0 to 636.0	447 titers (1/dilution) Interval 285.0 to 701.0
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.	303 titers (1/dilution) Interval 242.0 to 379.0	328 titers (1/dilution) Interval 219.0 to 491.0
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.	341 titers (1/dilution) Interval 275.0 to 423.0	309 titers (1/dilution) Interval 194.0 to 492.0
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.	233 titers (1/dilution) Interval 198.0 to 273.0	156 titers (1/dilution) Interval 115.0 to 212.0
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.	169 titers (1/dilution) Interval 144.0 to 199.0	127 titers (1/dilution) Interval 96.3 to 167.0
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.	150 titers (1/dilution) Interval 129.0 to 174.0	114 titers (1/dilution) Interval 85.2 to 153.0

SECONDARY outcome

Timeframe: Pre-booster injection (Day 0), 6 months, 12 months, and 24 months post-booster injection in CYD64

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

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: Month 6/Day 0	0.763 ratio Interval 0.643 to 0.904	0.502 ratio Interval 0.364 to 0.693
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: Month 12/Day 0	0.722 ratio Interval 0.607 to 0.859	0.483 ratio Interval 0.366 to 0.638
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 1: Month 24/Day 0	0.642 ratio Interval 0.532 to 0.774	0.509 ratio Interval 0.382 to 0.678
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: Month 6/Day 0	1.14 ratio Interval 0.922 to 1.4	0.998 ratio Interval 0.716 to 1.39
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: Month 12/Day 0	0.651 ratio Interval 0.539 to 0.786	0.630 ratio Interval 0.46 to 0.863
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 2: Month 24/Day 0	0.579 ratio Interval 0.473 to 0.709	0.548 ratio Interval 0.373 to 0.806
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: Month 6/Day 0	1.34 ratio Interval 1.09 to 1.65	0.957 ratio Interval 0.701 to 1.31
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: Month 12/Day 0	0.786 ratio Interval 0.652 to 0.947	0.667 ratio Interval 0.505 to 0.883
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 3: Month 24/Day 0	0.878 ratio Interval 0.749 to 1.03	0.682 ratio Interval 0.523 to 0.89
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: Month 6/Day 0	1.42 ratio Interval 1.17 to 1.72	0.912 ratio Interval 0.691 to 1.2
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: Month 12/Day 0	1.02 ratio Interval 0.846 to 1.22	0.709 ratio Interval 0.553 to 0.909
GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo Dengue Virus Serotype 4: Month 24/Day 0	0.890 ratio Interval 0.753 to 1.05	0.684 ratio Interval 0.534 to 0.877

SECONDARY outcome

Timeframe: 6 months,12 months, and 24 months post-booster injection in CYD64

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

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=177 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
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.	91.4 percentage of participants	85.7 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 Serotype1:12 months Post-booster Inj.	92.9 percentage of participants	88.7 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 Serotype1:24 months Post-booster Inj.	87.2 percentage of participants	89.7 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 Serotype 2:6 months Post-booster Inj.	98.9 percentage of participants	92.1 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.	96.5 percentage of participants	91.9 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.	93.3 percentage of participants	91.4 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.	97.7 percentage of participants	95.2 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 Serotype3:12 months Post-booster Inj.	97.1 percentage of participants	96.8 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 Serotype3:24 months Post-booster Inj.	99.4 percentage of participants	94.8 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 Serotype 4:6 months Post-booster Inj.	98.9 percentage of participants	95.2 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 Serotype4:12 months Post-booster Inj.	97.6 percentage of participants	95.2 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.	98.8 percentage of participants	94.8 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.

Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: \>100 millimeters (mm).

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=187 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
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	46 Participants	12 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: 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 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°C; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 n=187 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).	CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64 n=64 Participants Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
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	13 Participants	6 Participants
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	1 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 Headache: Any Grade	87 Participants	22 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	11 Participants	2 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	47 Participants	19 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	5 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	60 Participants	19 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	2 Participants	2 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	52 Participants	14 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	3 Participants	1 Participants

Adverse Events

CYD Dengue Vaccine Booster Group

Serious events: 19 serious events

Other events: 115 other events

Deaths: 0 deaths

Placebo Group

Serious events: 5 serious events

Other events: 31 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CYD Dengue Vaccine Booster Group n=187 participants at risk Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).	Placebo Group n=64 participants at risk Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
General disorders Asthenia	27.8% 52/187 • Number of events 52 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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.	21.9% 14/64 • Number of events 14 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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	24.6% 46/187 • Number of events 46 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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.	18.8% 12/64 • Number of events 12 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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	25.1% 47/187 • Number of events 48 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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.	29.7% 19/64 • Number of events 19 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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 Pyrexia	8.0% 15/187 • 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 was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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.	9.4% 6/64 • Number of events 6 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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	32.1% 60/187 • Number of events 61 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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.	29.7% 19/64 • Number of events 19 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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	47.1% 88/187 • Number of events 90 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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.	34.4% 22/64 • 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 was collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data was collected throughout the study (up to 24 months after last vaccination). 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

Email: [email protected]

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