Trial Outcomes & Findings for Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers (NCT NCT01411241)

Last Updated: 2022-03-25

Results Overview

Antibodies (Ab) against diphtheria, tetanus toxoid, pertussis toxoid (PT), and filamentous hemaglutinin (FHA) was measured by enzyme-linked immunosorbent assay (ELISA), polyribosylribitol phosphate (PRP) by Farr-type radioimmunoassay, and poliovirus types 1, 2, and 3 by seroneutralization assay. Seroprotection was defined as \>=0.1 International Unit (IU)/mL for diphtheria toxoid and tetanus toxoid, \>=8 1/dil for poliovirus types 1, 2, and 3, and \>=1.0 μg/mL for PRP. Booster response to PT and FHA: participants whose pre-vaccination Ab titers were \< lower limit of quantitation (LLOQ), a booster response occurred if they had post-vaccination levels \>=4\* LLOQ; participants whose pre-vaccination Ab concentrations were \>=LLOQ but \<4\* LLOQ, a booster response occurred if they had a 4-fold increase (post/pre-vaccination levels \>=4); for participants whose pre-vaccination Ab concentrations were \>=4\* LLOQ, a booster response occurred if they had a 2-fold increase (post/pre-vaccination \>=2).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

720 participants

Primary outcome timeframe

28 days post-injection

Results posted on

2022-03-25

Participant Flow

Study participants were enrolled from 18 July 2011 to 31 July 2012 at 3 clinical sites in Mexico. The study planned for 732 participants; however, recruitment was stopped when 720 participants were enrolled due to the difficulty in enrolling participants.

A total of 720 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled, out of which 309 participants were randomized to Group 1 and 315 in Group 2, and 96 participants were not randomized to Group 1 or 2.

Participant milestones

Participant milestones
Measure	CYD Dengue Vaccine Group 1 Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a measles, mumps, rubella (MMR) vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Overall Study STARTED	309	315
Overall Study COMPLETED	298	293
Overall Study NOT COMPLETED	11	22

Reasons for withdrawal

Reasons for withdrawal
Measure	CYD Dengue Vaccine Group 1 Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a measles, mumps, rubella (MMR) vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Overall Study Protocol Violation	0	5
Overall Study Withdrawal by Subject	9	10
Overall Study Serious Adverse Event	0	3
Overall Study Lost to Follow-up	2	4

Baseline Characteristics

Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CYD Dengue Vaccine Group 1 n=309 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=315 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	Total n=624 Participants Total of all reporting groups
Age, Customized 1 month to 23 months	309 Participants n=5 Participants	315 Participants n=7 Participants	624 Participants n=5 Participants
Sex: Female, Male Female	146 Participants n=5 Participants	139 Participants n=7 Participants	285 Participants n=5 Participants
Sex: Female, Male Male	163 Participants n=5 Participants	176 Participants n=7 Participants	339 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days post-injection

Population: Per-protocol analysis set:all participants who had no protocol deviations (not meet inclusion/exclusion criteria,not received vaccine in time window, administration not done per protocol) and could impact Pentaxim vaccine immunogenicity up to Visit 06 (Month 07). Here, 'number analyzed'=participants with available data for each specified category.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Group 1 n=256 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=270 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Anti-diphtheria	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Anti-tetanus	100.0 Percentage of participants	99.6 Percentage of participants
Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Anti-polio 1	100.0 Percentage of participants	99.6 Percentage of participants
Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Anti-polio 2	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Anti-polio 3	100 Percentage of participants	99.6 Percentage of participants
Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Anti-PRP	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Anti-PT	96.5 Percentage of participants	97.0 Percentage of participants
Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Anti-FHA	93.0 Percentage of participants	93.3 Percentage of participants

SECONDARY outcome

Timeframe: Pre-injection 1 and 28 days post-injection 2 and 3

Population: Analysis was performed on Full analysis set for dengue immunogenicity which included participants randomized into the dengue immunogenicity subset who received at least one dose of CYD dengue vaccine. Here, 'number analyzed' = participants with available data for each specified category.

Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue plaque reduction neutralization test (PRNT).

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Group 1 n=109 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=107 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 1; Pre-injection 1	5.28 Titers (1/dilution) Interval 4.82 to 5.78	5.35 Titers (1/dilution) Interval 4.85 to 5.91
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 1; Post-injection 2	39.8 Titers (1/dilution) Interval 30.5 to 51.9	62.8 Titers (1/dilution) Interval 48.1 to 82.0
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 1; Post-injection 3	93.1 Titers (1/dilution) Interval 76.6 to 113.0	97.0 Titers (1/dilution) Interval 78.8 to 120.0
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 2; Pre-injection 1	5.22 Titers (1/dilution) Interval 4.89 to 5.57	5.53 Titers (1/dilution) Interval 5.04 to 6.07
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 2; Post-injection 2	109 Titers (1/dilution) Interval 80.2 to 149.0	121 Titers (1/dilution) Interval 89.3 to 164.0
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 2; Post-injection 3	189 Titers (1/dilution) Interval 156.0 to 228.0	208 Titers (1/dilution) Interval 166.0 to 261.0
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 3; Pre-injection 1	5.26 Titers (1/dilution) Interval 4.93 to 5.62	5.38 Titers (1/dilution) Interval 4.95 to 5.84
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 3; Post-injection 2	92.8 Titers (1/dilution) Interval 75.7 to 114.0	116 Titers (1/dilution) Interval 91.1 to 149.0
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 3; Post-injection 3	196 Titers (1/dilution) Interval 168.0 to 229.0	217 Titers (1/dilution) Interval 183.0 to 256.0
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 4; Pre-injection 1	5.11 Titers (1/dilution) Interval 4.94 to 5.28	5.00 Titers (1/dilution) Interval 5.0 to 5.0
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 4; Post-injection 2	57.8 Titers (1/dilution) Interval 44.5 to 75.2	104 Titers (1/dilution) Interval 81.7 to 131.0
Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 4; Post-injection 3	121 Titers (1/dilution) Interval 103.0 to 142.0	127 Titers (1/dilution) Interval 103.0 to 155.0

SECONDARY outcome

Timeframe: Pre-injection 1 and 28 days post-injection 2 and 3

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

Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue PRNT.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Group 1 n=109 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=107 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 1: Post-inj 2 value/pre-inj 1 value	3.81 Titer ratio Interval 2.95 to 4.93	5.97 Titer ratio Interval 4.64 to 7.68
Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 1: Post-inj 3 value/pre-inj 1 value	8.91 Titer ratio Interval 7.4 to 10.7	9.20 Titer ratio Interval 7.55 to 11.2
Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 2: Post-inj 2 value/pre-inj 1 value	10.6 Titer ratio Interval 7.77 to 14.5	11.5 Titer ratio Interval 8.5 to 15.4
Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 2: Post-inj 3 value/pre-inj 1 value	18.3 Titer ratio Interval 15.1 to 22.1	19.6 Titer ratio Interval 15.6 to 24.7
Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 3: Post-inj 2 value/pre-inj 1 value	8.97 Titer ratio Interval 7.33 to 11.0	11.1 Titer ratio Interval 8.73 to 14.1
Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 3: Post-inj 3 value/pre-inj 1 value	19.1 Titer ratio Interval 16.4 to 22.2	20.6 Titer ratio Interval 17.4 to 24.4
Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 4: Post-inj 2 value/pre-inj 1 value	5.73 Titer ratio Interval 4.4 to 7.45	10.0 Titer ratio Interval 7.96 to 12.6
Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 4: Post-inj 3 value/pre-inj 1 value	12.0 Titer ratio Interval 10.2 to 14.1	12.6 Titer ratio Interval 10.3 to 15.5

SECONDARY outcome

Timeframe: Pre-injection 1 and 28 days post-injection 2 and 3

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

Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers \>=10 (1/dilution).

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Group 1 n=109 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=107 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 1; Pre-injection 1	1.8 Percentage of participants	2.8 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 1; Post-injection 2	84.8 Percentage of participants	92.2 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 1; Post-injection 3	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 2; Pre-injection 1	1.8 Percentage of participants	4.7 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 2; Post-injection 2	98.1 Percentage of participants	96.1 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 2; Post-injection 3	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 3; Pre-injection 1	2.8 Percentage of participants	3.7 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 3; Post-injection 2	100.0 Percentage of participants	98.1 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 3; Post-injection 3	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 4; Pre-injection 1	1.8 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 4; Post-injection 2	90.5 Percentage of participants	96.1 Percentage of participants
Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine Serotype 4; Post-injection 3	100.0 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: Pre-injection 1 and 28 days post-injection 2 and 3

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

Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers \>=10 (1/dilution).

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Group 1 n=109 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=107 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine At least 1 serotype; Pre-injection 1	4.6 Percentage of participants	8.4 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine At least 1 serotype; Post-injection 2	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine At least 1 serotype; Post-injection 3	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine At least 2 serotypes; Pre-injection 1	1.8 Percentage of participants	1.9 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine At least 2 serotypes; Post-injection 2	100.0 Percentage of participants	98.1 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine At least 2 serotypes; Post-injection 3	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine At least 3 serotypes; Pre-injection 1	0.9 Percentage of participants	0.9 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine At least 3 serotypes; Post-injection 2	94.3 Percentage of participants	95.1 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine At least 3 serotypes; Post-injection 3	100.0 Percentage of participants	100.0 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine All 4 serotypes; Pre-injection 1	0.9 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine All 4 serotypes; Post-injection 2	79.0 Percentage of participants	89.3 Percentage of participants
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine All 4 serotypes; Post-injection 3	100.0 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 0 up to Day 14 post-first injection

Population: Analysis was performed on Safety analysis set which included participants who received at least one dose of CYD dengue vaccine, Pentaxim vaccine or placebo. Here, 'number analyzed' = participants with available data for each specified category.

Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade (Grd) 3 Solicited injection site reactions: Tenderness, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5 degree Celsius (°C); Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: Sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Group 1 n=309 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=315 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Injection site Tenderness	29.9 Percentage of participants	33.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Grade 3 Injection site Tenderness	0.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Injection site Erythema	14.0 Percentage of participants	15.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Grade 3 Injection site Erythema	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Injection site Swelling	4.9 Percentage of participants	10.9 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Grade 3 Injection site Swelling	0.0 Percentage of participants	0.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Fever	25.1 Percentage of participants	28.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Grade 3 Fever	1.6 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Vomiting	18.8 Percentage of participants	17.6 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Grade 3 Vomiting	1.3 Percentage of participants	0.6 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Crying abnormal	36.4 Percentage of participants	38.5 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Grade 3 Crying abnormal	2.3 Percentage of participants	2.2 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Drowsiness	24.0 Percentage of participants	23.4 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Grade 3 Drowsiness	1.9 Percentage of participants	1.6 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Appetite lost	32.5 Percentage of participants	34.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Grade 3 Appetite lost	4.5 Percentage of participants	4.5 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Injection site Irritability	47.1 Percentage of participants	45.5 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine Grade 3 Injection site Irritability	3.2 Percentage of participants	4.2 Percentage of participants

SECONDARY outcome

Timeframe: Day 0 up to Day 14 post-booster injection

Population: Analysis was performed on Safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.

Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5°C; Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable; and Extensive swelling, severe.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Group 1 n=309 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=314 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Injection site Tenderness	43.2 Percentage of participants	42.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Injection site Tenderness	1.0 Percentage of participants	0.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Injection site Tenderness; Post- Pentaxim	37.5 Percentage of participants	37.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Injection site Tenderness; Post- Pentaxim	1.0 Percentage of participants	0.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Injection site Tenderness; Post-CYD dengue/placebo	33.2 Percentage of participants	30.5 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grd 3 Inj. site Tenderness;Post-CYD dengue/placebo	0.0 Percentage of participants	0.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Injection site Erythema	15.0 Percentage of participants	20.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Injection site Erythema	0.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Injection site Erythema; Post-Pentaxim	13.0 Percentage of participants	17.8 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Injection site Erythema; Post- Pentaxim	0.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Injection site Erythema; Post-CYD dengue/placebo	8.3 Percentage of participants	13.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grd 3 Inj. site Erythema; Post-CYD dengue/placebo	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Injection site Swelling	11.6 Percentage of participants	17.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Injection site Swelling	0.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Injection site Swelling; Post-Pentaxim	9.4 Percentage of participants	16.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Injection site Swelling; Post- Pentaxim	0.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Injection site Swelling; Post-CYD dengue/placebo	5.0 Percentage of participants	7.2 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grd 3 Inj. site Swelling; Post-CYD dengue/placebo	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Injection site extensive swelling; Post- Pentaxim	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grd 3 Inj. site extensive swelling; Post- Pentaxim	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Fever	29.1 Percentage of participants	24.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Fever	1.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Vomiting	11.7 Percentage of participants	11.8 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Vomiting	1.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Crying abnormal	33.7 Percentage of participants	30.8 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Crying abnormal	0.7 Percentage of participants	1.6 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Drowsiness	19.7 Percentage of participants	17.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Drowsiness	1.0 Percentage of participants	0.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Appetite lost	23.3 Percentage of participants	23.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Appetite lost	3.7 Percentage of participants	3.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Irritability	37.7 Percentage of participants	39.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Irritability	1.0 Percentage of participants	0.7 Percentage of participants

SECONDARY outcome

Timeframe: Day 0 up to Day 14 post-second injection

Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5°C; Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Group 1 n=301 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=302 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Injection site Tenderness	24.5 Percentage of participants	25.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Injection site Tenderness	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Injection site Erythema	8.2 Percentage of participants	10.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Injection site Erythema	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Injection site Swelling	4.4 Percentage of participants	5.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Injection site Swelling	0.0 Percentage of participants	0.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Fever	16.7 Percentage of participants	18.1 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Fever	0.0 Percentage of participants	0.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Vomiting	6.8 Percentage of participants	8.8 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Vomiting	0.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Crying abnormal	21.2 Percentage of participants	24.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Crying abnormal	0.0 Percentage of participants	0.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Drowsiness	11.9 Percentage of participants	14.9 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Drowsiness	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Appetite lost	17.7 Percentage of participants	20.9 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Appetite lost	1.7 Percentage of participants	1.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Irritability	23.9 Percentage of participants	25.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine Grade 3 Irritability	0.3 Percentage of participants	1.0 Percentage of participants

SECONDARY outcome

Timeframe: Day 0 up to Day 14 post-third injection

Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 mm. Grade 3 Solicited systemic reactions: Fever: \>39.5°C; Vomiting: \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine Group 1 n=298 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=297 Participants Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Injection site Tenderness	19.8 Percentage of participants	25.4 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Grade 3 Injection site Tenderness	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Injection site Erythema	6.7 Percentage of participants	5.8 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Grade 3 Injection site Erythema	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Injection site Swelling	2.0 Percentage of participants	2.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Grade 3 Injection site Swelling	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Fever	16.0 Percentage of participants	15.2 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Grade 3 Fever	1.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Vomiting	4.4 Percentage of participants	7.2 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Grade 3 Vomiting	0.7 Percentage of participants	1.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Crying abnormal	21.5 Percentage of participants	18.9 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Grade 3 Crying abnormal	0.7 Percentage of participants	0.3 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Drowsiness	10.4 Percentage of participants	10.0 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Grade 3 Drowsiness	0.7 Percentage of participants	0.7 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Appetite lost	18.8 Percentage of participants	18.6 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Grade 3 Appetite lost	1.3 Percentage of participants	2.4 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Irritability	23.8 Percentage of participants	20.6 Percentage of participants
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine Grade 3 Irritability	1.0 Percentage of participants	0.0 Percentage of participants

Adverse Events

CYD Dengue Vaccine Group 1

Serious events: 17 serious events

Other events: 145 other events

Deaths: 0 deaths

CYD Dengue Vaccine Group 2

Serious events: 21 serious events

Other events: 142 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Director

Sanofi Pasteur

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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Measure	CYD Dengue Vaccine Group 1 n=309 participants at risk Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=315 participants at risk Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Infections and infestations Gastroenteritis bacterial	0.32% 1/309 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.00% 0/315 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Injury, poisoning and procedural complications Accidental exposure	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Injury, poisoning and procedural complications Head injury	0.32% 1/309 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.00% 0/315 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myelomonocytic leukaemia	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Congenital, familial and genetic disorders Phimosis	0.32% 1/309 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.00% 0/315 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.65% 2/309 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Nervous system disorders Encephalitis	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Nervous system disorders Febrile convulsion	1.6% 5/309 • Number of events 6 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	2.2% 7/315 • Number of events 10 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Gastrointestinal disorders Diarrhoea	0.32% 1/309 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Amoebic dysentery	0.32% 1/309 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.00% 0/315 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Ascariasis	0.32% 1/309 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.00% 0/315 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Bronchopneumonia	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.63% 2/315 • Number of events 3 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Cellulitis	0.32% 1/309 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.00% 0/315 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Dengue fever	0.32% 1/309 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.00% 0/315 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Gastroenteritis	0.32% 1/309 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.00% 0/315 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Gastroenteritis viral	0.32% 1/309 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.00% 0/315 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Pneumonia	0.00% 0/309 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	0.32% 1/315 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.

Measure	CYD Dengue Vaccine Group 1 n=309 participants at risk Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).	CYD Dengue Vaccine Group 2 n=315 participants at risk Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months).
Nervous system disorders Drowsiness; Post-injection 1	24.0% 74/308 • Number of events 74 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	23.4% 73/312 • Number of events 73 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
General disorders Injection site Tenderness; Post-injection 1	29.8% 92/309 • Number of events 92 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	33.3% 104/312 • Number of events 104 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
General disorders Injection site Erythema; Post-injection 1	14.0% 43/308 • Number of events 43 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	15.7% 49/312 • Number of events 49 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
General disorders Injection site Swelling; Post-injection 1	4.9% 15/308 • Number of events 15 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	10.9% 34/312 • Number of events 34 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
General disorders Fever; Post-injection 1	25.1% 77/307 • Number of events 77 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	28.1% 88/313 • Number of events 88 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Psychiatric disorders Crying abnormal; Post-injection 1	36.4% 112/308 • Number of events 112 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	38.5% 120/312 • Number of events 120 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Psychiatric disorders Irritability; Post-injection 1	47.1% 145/308 • Number of events 145 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	45.5% 142/312 • Number of events 142 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Gastrointestinal disorders Diarrhoea	11.0% 34/309 • Number of events 41 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	10.8% 34/315 • Number of events 37 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Gastrointestinal disorders Vomiting; Post-injection 1	18.8% 58/308 • Number of events 58 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	17.6% 55/312 • Number of events 55 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Metabolism and nutrition disorders Appetite lost; Post-injection 1	32.5% 100/308 • Number of events 100 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	34.7% 108/311 • Number of events 108 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Gastroenteritis	17.8% 55/309 • Number of events 61 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	14.9% 47/315 • Number of events 51 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Nasopharyngitis	35.3% 109/309 • Number of events 147 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	33.0% 104/315 • Number of events 132 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Pharyngitis	16.2% 50/309 • Number of events 60 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	18.1% 57/315 • Number of events 69 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Pharyngotonsillitis	7.8% 24/309 • Number of events 28 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	10.5% 33/315 • Number of events 33 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.
Infections and infestations Rhinitis	8.1% 25/309 • Number of events 26 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.	7.0% 22/315 • Number of events 26 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-third CYD injection (up to 18 months). Analysis was performed on Safety analysis set.