Trial Outcomes & Findings for Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix® (NCT NCT02979535)

Last Updated: 2022-03-25

Results Overview

GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an enzyme-linked immunosorbent assay (ELISA) method. Dengue seropositive participants at baseline were defined as those participants with titers greater than or equal to (\>=) 10 (1/dilutions \[dil\]) for at least one serotype with the parental dengue virus strain.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

480 participants

Primary outcome timeframe

28 days after the last Cervarix vaccination

Results posted on

2022-03-25

Participant Flow

Study participants were enrolled from 16 November 2016 to 13 March 2017 at 3 centers in Mexico.

A total of 480 participants were enrolled and randomized in this study.

Participant milestones

Participant milestones
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) Participants received 3 doses of CYD dengue vaccine 0.5 milliliter (mL) subcutaneously (SC) at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL Intramuscularly (IM) concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Overall Study STARTED	239	241
Overall Study Safety Analysis Set	237	241
Overall Study COMPLETED	144	140
Overall Study NOT COMPLETED	95	101

Reasons for withdrawal

Reasons for withdrawal
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) Participants received 3 doses of CYD dengue vaccine 0.5 milliliter (mL) subcutaneously (SC) at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL Intramuscularly (IM) concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Overall Study Non compliance with the protocol	78	82
Overall Study Consent withdrawn by participant	11	18
Overall Study Lost to Follow-up	6	1

Baseline Characteristics

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=239 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=241 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.	Total n=480 Participants Total of all reporting groups
Age, Continuous	9.50 years STANDARD_DEVIATION 1.00 • n=5 Participants	9.56 years STANDARD_DEVIATION 1.05 • n=7 Participants	9.53 years STANDARD_DEVIATION 1.03 • n=5 Participants
Sex: Female, Male Female	239 Participants n=5 Participants	241 Participants n=7 Participants	480 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race: Not reported	239 Participants n=5 Participants	241 Participants n=7 Participants	480 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days after the last Cervarix vaccination

Population: Analysis was performed on per-protocol analysis set (PPS) for Cervarix which included participants who received at least one dose of Cervarix vaccine and had no relevant protocol deviations.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=118 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=114 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-16	2149 Endotoxin Units per milliliter (EU/mL) Interval 1877.0 to 2460.0	2268 Endotoxin Units per milliliter (EU/mL) Interval 1946.0 to 2644.0
Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-18	833 Endotoxin Units per milliliter (EU/mL) Interval 727.0 to 954.0	845 Endotoxin Units per milliliter (EU/mL) Interval 723.0 to 987.0

PRIMARY outcome

Timeframe: 28 days after third CYD dengue vaccination

Population: Analysis was performed on the full analysis set (FAS) which was defined as the subset of participants who received at least one dose of the study vaccine. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=143 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=140 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 1	384 titer (1/dilution) Interval 291.0 to 507.0	393 titer (1/dilution) Interval 292.0 to 528.0
GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 2	670 titer (1/dilution) Interval 535.0 to 839.0	735 titer (1/dilution) Interval 575.0 to 940.0
GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 3	357 titer (1/dilution) Interval 305.0 to 418.0	388 titer (1/dilution) Interval 325.0 to 463.0
GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 4	247 titer (1/dilution) Interval 213.0 to 287.0	265 titer (1/dilution) Interval 220.0 to 320.0

SECONDARY outcome

Timeframe: Day 0 and 28 days after each Cervarix vaccination

Population: Analysis was performed on FAS population. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants with available data for specified categories.

The GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=154 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=151 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-16: Day 0	1.61 EU/mL Interval 1.31 to 1.97	1.58 EU/mL Interval 1.29 to 1.93
GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-16: 28 days post vaccination 1	118 EU/mL Interval 98.7 to 142.0	140 EU/mL Interval 116.0 to 170.0
GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-16: 28 days post vaccination 2	2089 EU/mL Interval 1852.0 to 2356.0	2162 EU/mL Interval 1869.0 to 2501.0
GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-18: Day 0	1.34 EU/mL Interval 1.15 to 1.55	1.34 EU/mL Interval 1.16 to 1.54
GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-18: 28 days post vaccination 1	53.8 EU/mL Interval 44.1 to 65.7	68.6 EU/mL Interval 56.5 to 83.4
GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-18: 28 days post vaccination 2	846 EU/mL Interval 752.0 to 951.0	846 EU/mL Interval 728.0 to 984.0

SECONDARY outcome

Timeframe: 28 days after each Cervarix vaccination

Population: Analysis was performed on FAS population. Here, "overall number of participants" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants with available data for specified category.

Neutralizing antibodies against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (greater than \[\>\] lower limit of quantitation \[LLOQ\] of the assay) or \>=4-fold rise in antibody titer if seropositive at baseline (i.e., at least one antibody levels against Cervarix HPV antigens \> LLOQ at baseline). The LLOQ for HPV-16 and HPV-18 was less than (\<) 2.0 International Units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=154 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=151 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-16: 28 days post-vaccination 1	98.0 percentage of participants Interval 94.3 to 99.6	99.3 percentage of participants Interval 96.4 to 100.0
Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-16: 28 days post-vaccination 2	98.7 percentage of participants Interval 95.2 to 99.8	99.3 percentage of participants Interval 96.3 to 100.0
Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-18: 28 days post-vaccination 1	100.0 percentage of participants Interval 97.6 to 100.0	98.7 percentage of participants Interval 95.3 to 99.8
Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants HPV-18: 28 days post-vaccination 2	99.3 percentage of participants Interval 96.3 to 100.0	100.0 percentage of participants Interval 97.5 to 100.0

SECONDARY outcome

Timeframe: Day 0 and 28 days after each CYD dengue vaccine vaccination

The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the PRNT50 assay. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=154 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=151 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 1: Day 0	150 titer (1/dilution) Interval 99.7 to 225.0	108 titer (1/dilution) Interval 72.1 to 163.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 1: 28 days post-vaccination 1	711 titer (1/dilution) Interval 498.0 to 1016.0	586 titer (1/dilution) Interval 409.0 to 840.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 1: 28 days post-vaccination 2	460 titer (1/dilution) Interval 336.0 to 630.0	476 titer (1/dilution) Interval 337.0 to 674.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 1: 28 days post-vaccination 3	384 titer (1/dilution) Interval 291.0 to 507.0	393 titer (1/dilution) Interval 292.0 to 528.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 2: Day 0	193 titer (1/dilution) Interval 141.0 to 263.0	188 titer (1/dilution) Interval 135.0 to 262.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 2: 28 days post-vaccination 1	1168 titer (1/dilution) Interval 879.0 to 1552.0	1163 titer (1/dilution) Interval 847.0 to 1597.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 2: 28 days post-vaccination 2	618 titer (1/dilution) Interval 492.0 to 776.0	703 titer (1/dilution) Interval 541.0 to 913.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 2: 28 days post-vaccination 3	670 titer (1/dilution) Interval 535.0 to 839.0	735 titer (1/dilution) Interval 575.0 to 940.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 3: Day 0	98.5 titer (1/dilution) Interval 72.2 to 135.0	90.2 titer (1/dilution) Interval 67.2 to 121.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 3: 28 days post-vaccination 1	499 titer (1/dilution) Interval 386.0 to 644.0	503 titer (1/dilution) Interval 385.0 to 656.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 3: 28 days post-vaccination 2	299 titer (1/dilution) Interval 251.0 to 358.0	361 titer (1/dilution) Interval 294.0 to 445.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 3: 28 days post-vaccination 3	357 titer (1/dilution) Interval 305.0 to 418.0	388 titer (1/dilution) Interval 325.0 to 463.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 4: Day 0	47.1 titer (1/dilution) Interval 34.6 to 64.0	38.0 titer (1/dilution) Interval 28.4 to 50.9
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 4: 28 days post-vaccination 1	423 titer (1/dilution) Interval 336.0 to 532.0	449 titer (1/dilution) Interval 365.0 to 552.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 4: 28 days post-vaccination 2	267 titer (1/dilution) Interval 225.0 to 316.0	262 titer (1/dilution) Interval 219.0 to 314.0
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 4: 28 days post-vaccination 3	247 titer (1/dilution) Interval 213.0 to 287.0	265 titer (1/dilution) Interval 220.0 to 320.0

SECONDARY outcome

Timeframe: Day 0 and 28 days after each CYD dengue vaccine vaccination

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=154 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=151 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 1: Day 0	74.0 percentage of participants Interval 66.4 to 80.8	68.9 percentage of participants Interval 60.8 to 76.2
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 1: 28 days post-vaccination 1	94.7 percentage of participants Interval 89.8 to 97.7	95.3 percentage of participants Interval 90.5 to 98.1
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 1: 28 days post-vaccination 2	97.3 percentage of participants Interval 93.3 to 99.3	97.3 percentage of participants Interval 93.1 to 99.2
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 1: 28 days post-vaccination 3	99.3 percentage of participants Interval 96.2 to 100.0	97.9 percentage of participants Interval 93.9 to 99.6
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 2: Day 0	92.9 percentage of participants Interval 87.6 to 96.4	91.4 percentage of participants Interval 85.7 to 95.3
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 2: 28 days post-vaccination 1	96.7 percentage of participants Interval 92.4 to 98.9	93.9 percentage of participants Interval 88.8 to 97.2
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 2: 28 days post-vaccination 2	100.0 percentage of participants Interval 97.6 to 100.0	98.6 percentage of participants Interval 95.1 to 99.8
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 2: 28 days post-vaccination 3	100.0 percentage of participants Interval 97.5 to 100.0	100.0 percentage of participants Interval 97.4 to 100.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 3: Day 0	82.5 percentage of participants Interval 75.5 to 88.1	83.4 percentage of participants Interval 76.5 to 89.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 3: 28 days post-vaccination 1	96.7 percentage of participants Interval 92.4 to 98.9	96.6 percentage of participants Interval 92.3 to 98.9
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 3: 28 days post-vaccination 2	99.3 percentage of participants Interval 96.3 to 100.0	100.0 percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 3: 28 days post-vaccination 3	99.3 percentage of participants Interval 96.2 to 100.0	100.0 percentage of participants Interval 97.4 to 100.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 4: Day 0	68.8 percentage of participants Interval 60.9 to 76.0	66.9 percentage of participants Interval 58.8 to 74.3
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 4: 28 days post-vaccination 1	97.3 percentage of participants Interval 93.3 to 99.3	98.6 percentage of participants Interval 95.2 to 99.8
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 4: 28 days post-vaccination 2	100.0 percentage of participants Interval 97.6 to 100.0	100.0 percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants Serotype 4: 28 days post-vaccination 3	100.0 percentage of participants Interval 97.5 to 100.0	98.6 percentage of participants Interval 94.9 to 99.8

SECONDARY outcome

Timeframe: Day 0 and 28 days after each CYD dengue vaccination

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=154 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=151 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 1 Serotype: Day 0	100.0 percentage of participants Interval 97.6 to 100.0	100.0 percentage of participants Interval 97.6 to 100.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 1 Serotype: 28 days post-vaccination 1	99.3 percentage of participants Interval 96.3 to 100.0	99.3 percentage of participants Interval 96.3 to 100.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 1 Serotype: 28 days post-vaccination 2	100.0 percentage of participants Interval 97.6 to 100.0	100.0 percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 1 Serotype: 28 days post-vaccination 3	100.0 percentage of participants Interval 97.5 to 100.0	100.0 percentage of participants Interval 97.4 to 100.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 2 Serotype: Day 0	84.4 percentage of participants Interval 77.7 to 89.8	82.8 percentage of participants Interval 75.8 to 88.4
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 2 Serotype: 28 days post-vaccination 1	98.0 percentage of participants Interval 94.3 to 99.6	98.0 percentage of participants Interval 94.2 to 99.6
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 2 Serotype: 28 days post-vaccination 2	100.0 percentage of participants Interval 97.6 to 100.0	100.0 percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 2 Serotype: 28 days post-vaccination 3	100.0 percentage of participants Interval 97.5 to 100.0	100.0 percentage of participants Interval 97.4 to 100.0
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 3 Serotype: Day 0	74.0 percentage of participants Interval 66.4 to 80.8	72.8 percentage of participants Interval 65.0 to 79.8
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 3 Serotype: 28 days post-vaccination 1	95.3 percentage of participants Interval 90.6 to 98.1	94.6 percentage of participants Interval 89.6 to 97.6
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 3 Serotype: 28 days post-vaccination 2	99.3 percentage of participants Interval 96.3 to 100.0	98.6 percentage of participants Interval 95.1 to 99.8
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants At least 3 Serotype: 28 days post-vaccination 3	100.0 percentage of participants Interval 97.5 to 100.0	98.6 percentage of participants Interval 94.9 to 99.8
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants All 4 Serotypes: Day 0	59.7 percentage of participants Interval 51.5 to 67.6	55.0 percentage of participants Interval 46.7 to 63.1
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants All 4 Serotypes: 28 days post-vaccination 1	92.7 percentage of participants Interval 87.3 to 96.3	92.6 percentage of participants Interval 87.1 to 96.2
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants All 4 Serotypes: 28 days post-vaccination 2	97.3 percentage of participants Interval 93.3 to 99.3	97.3 percentage of participants Interval 93.1 to 99.2
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants All 4 Serotypes: 28 days post-vaccination 3	98.6 percentage of participants Interval 95.0 to 99.8	97.9 percentage of participants Interval 93.9 to 99.6

SECONDARY outcome

Timeframe: Day 0 and 28 days after each CYD dengue vaccination

Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (\<10, \>=10 and \>=100 \[1/dil\]) against each dengue virus serotypes of CYD were reported.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=154 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=151 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Pre-vaccination 1 <10 (1/dil)	26.0 percentage of participants Interval 19.2 to 33.6	31.1 percentage of participants Interval 23.8 to 39.2
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Pre-vaccination 1 >=10 (1/dil)	74.0 percentage of participants Interval 66.4 to 80.8	68.9 percentage of participants Interval 60.8 to 76.2
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Pre-vaccination 1 >=100 (1/dil)	61.0 percentage of participants Interval 52.9 to 68.8	56.3 percentage of participants Interval 48.0 to 64.3
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Post-vaccination 1 <10 (1/dil)	5.3 percentage of participants Interval 2.3 to 10.2	4.7 percentage of participants Interval 1.9 to 9.5
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Post-vaccination 1 >=10 (1/dil)	94.7 percentage of participants Interval 89.8 to 97.7	95.3 percentage of participants Interval 90.5 to 98.1
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Post-vaccination 1 >=100 (1/dil)	82.0 percentage of participants Interval 74.9 to 87.8	78.4 percentage of participants Interval 70.9 to 84.7
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Post-vaccination 2 <10 (1/dil)	2.7 percentage of participants Interval 0.7 to 6.7	2.7 percentage of participants Interval 0.8 to 6.9
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Post-vaccination 2 >=10 (1/dil)	97.3 percentage of participants Interval 93.3 to 99.3	97.3 percentage of participants Interval 93.1 to 99.2
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Post-vaccination 2 >=100 (1/dil)	77.2 percentage of participants Interval 69.6 to 83.7	72.6 percentage of participants Interval 64.6 to 79.7
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Post-vaccination 3 <10 (1/dil)	0.7 percentage of participants Interval 0.0 to 3.8	2.1 percentage of participants Interval 0.4 to 6.1
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Post-vaccination 3 >=10 (1/dil)	99.3 percentage of participants Interval 96.2 to 100.0	97.9 percentage of participants Interval 93.9 to 99.6
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 1: Post-vaccination 3 >=100 (1/dil)	74.8 percentage of participants Interval 66.9 to 81.7	76.4 percentage of participants Interval 68.5 to 83.2
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Pre-vaccination 1 <10 (1/dil)	7.1 percentage of participants Interval 3.6 to 12.4	8.6 percentage of participants Interval 4.7 to 14.3
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Pre-vaccination 1 >=10 (1/dil)	92.9 percentage of participants Interval 87.6 to 96.4	91.4 percentage of participants Interval 85.7 to 95.3
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Pre-vaccination 1 >=100 (1/dil)	59.1 percentage of participants Interval 50.9 to 66.9	61.6 percentage of participants Interval 53.3 to 69.4
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Post-vaccination 1 <10 (1/dil)	3.3 percentage of participants Interval 1.1 to 7.6	6.1 percentage of participants Interval 2.8 to 11.2
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Post-vaccination 1 >=10 (1/dil)	96.7 percentage of participants Interval 92.4 to 98.9	93.9 percentage of participants Interval 88.8 to 97.2
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Post-vaccination 1 >=100 (1/dil)	91.3 percentage of participants Interval 85.6 to 95.3	91.9 percentage of participants Interval 86.3 to 95.7
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Post-vaccination 2 <10 (1/dil)	0.0 percentage of participants Interval 0.0 to 2.4	1.4 percentage of participants Interval 0.2 to 4.9
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Post-vaccination 2 >=10 (1/dil)	100.0 percentage of participants Interval 97.6 to 100.0	98.6 percentage of participants Interval 95.1 to 99.8
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Post-vaccination 2 >=100 (1/dil)	90.6 percentage of participants Interval 84.7 to 94.8	90.4 percentage of participants Interval 84.4 to 94.7
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Post-vaccination 3 <10 (1/dil)	0.0 percentage of participants Interval 0.0 to 2.5	0.0 percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Post-vaccination 3 >=10 (1/dil)	100.0 percentage of participants Interval 97.5 to 100.0	100.0 percentage of participants Interval 97.4 to 100.0
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 2: Post-vaccination 3 >=100 (1/dil)	95.1 percentage of participants Interval 90.2 to 98.0	90.7 percentage of participants Interval 84.6 to 95.0
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Pre-vaccination 1 <10 (1/dil)	17.5 percentage of participants Interval 11.9 to 24.5	16.6 percentage of participants Interval 11.0 to 23.5
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Pre-vaccination 1 >=10 (1/dil)	82.5 percentage of participants Interval 75.5 to 88.1	83.4 percentage of participants Interval 76.5 to 89.0
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Pre-vaccination 1 >=100 (1/dil)	51.3 percentage of participants Interval 43.1 to 59.4	49.0 percentage of participants Interval 40.8 to 57.3
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Post-vaccination 1 <10 (1/dil)	3.3 percentage of participants Interval 1.1 to 7.6	3.4 percentage of participants Interval 1.1 to 7.7
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Post-vaccination 1 >=10 (1/dil)	96.7 percentage of participants Interval 92.4 to 98.9	96.6 percentage of participants Interval 92.3 to 98.9
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Post-vaccination 1 >=100 (1/dil)	88.7 percentage of participants Interval 82.5 to 93.3	87.8 percentage of participants Interval 81.5 to 92.6
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Post-vaccination 2 <10 (1/dil)	0.7 percentage of participants Interval 0.0 to 3.7	0.0 percentage of participants Interval 0.0 to 2.5
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Post-vaccination 2 >=10 (1/dil)	99.3 percentage of participants Interval 96.3 to 100.0	100.0 percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Post-vaccination 2 >=100 (1/dil)	87.2 percentage of participants Interval 80.8 to 92.1	87.0 percentage of participants Interval 80.4 to 92.0
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Post-vaccination 3 <10 (1/dil)	0.7 percentage of participants Interval 0.0 to 3.8	0.0 percentage of participants Interval 0.0 to 2.6
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Post-vaccination 3 >=10 (1/dil)	99.3 percentage of participants Interval 96.2 to 100.0	100.0 percentage of participants Interval 97.4 to 100.0
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 3: Post-vaccination 3 >=100 (1/dil)	94.4 percentage of participants Interval 89.3 to 97.6	90.7 percentage of participants Interval 84.6 to 95.0
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Pre-vaccination 1 <10 (1/dil)	31.2 percentage of participants Interval 24.0 to 39.1	33.1 percentage of participants Interval 25.7 to 41.2
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Pre-vaccination 1 >=10 (1/dil)	68.8 percentage of participants Interval 60.9 to 76.0	66.9 percentage of participants Interval 58.8 to 74.3
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Pre-vaccination 1 >=100 (1/dil)	33.1 percentage of participants Interval 25.8 to 41.1	29.8 percentage of participants Interval 22.6 to 37.8
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Post-vaccination 1 <10 (1/dil)	2.7 percentage of participants Interval 0.7 to 6.7	1.4 percentage of participants Interval 0.2 to 4.8
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Post-vaccination 1 >=10 (1/dil)	97.3 percentage of participants Interval 93.3 to 99.3	98.6 percentage of participants Interval 95.2 to 99.8
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Post-vaccination 1 >=100 (1/dil)	87.3 percentage of participants Interval 80.9 to 92.2	89.9 percentage of participants Interval 83.8 to 94.2
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Post-vaccination 2 <10 (1/dil)	0.0 percentage of participants Interval 0.0 to 2.4	0.0 percentage of participants Interval 0.0 to 2.5
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Post-vaccination 2 >=10 (1/dil)	100.0 percentage of participants Interval 97.6 to 100.0	100.0 percentage of participants Interval 97.5 to 100.0
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Post-vaccination 2 >=100 (1/dil)	82.6 percentage of participants Interval 75.5 to 88.3	80.1 percentage of participants Interval 72.7 to 86.3
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Post-vaccination 3 <10 (1/dil)	0.0 percentage of participants Interval 0.0 to 2.5	1.4 percentage of participants Interval 0.2 to 5.1
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Post-vaccination 3 >=10 (1/dil)	100.0 percentage of participants Interval 97.5 to 100.0	98.6 percentage of participants Interval 94.9 to 99.8
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants Serotype 4: Post-vaccination 3 >=100 (1/dil)	83.2 percentage of participants Interval 76.1 to 88.9	83.6 percentage of participants Interval 76.4 to 89.3

SECONDARY outcome

Timeframe: Within 30 minutes after each and any vaccination

Population: Analysis was performed on safety analysis set which included those participants who had received at least one dose of the study vaccines. Here, "number analyzed" signifies participants with available data for specified categories.

Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=237 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=241 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine After any CYD/Cervarix vaccination	0 Participants	0 Participants
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine Post CYD/Cervarix vaccination 1	0 Participants	0 Participants
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine Post CYD/Cervarix vaccination 2	0 Participants	0 Participants
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine Post CYD vaccination 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 7 days after each and any vaccination

Population: Analysis was performed on safety analysis set. Here, "number analyzed" signifies participants with available data for specified categories.

Solicited injection site reactions included pain, erythema, and swelling.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=237 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=241 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Pain: Post any CYD/Cervarix vaccine	212 Participants	221 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Pain: Post CYD/Cervarix vaccination 1	202 Participants	206 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Pain: Post CYD/Cervarix vaccination 2	173 Participants	169 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Pain: Post CYD vaccination 3	65 Participants	59 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Erythema: Post any CYD/Cervarix vaccine	64 Participants	61 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Erythema: Post CYD/Cervarix vaccination 1	49 Participants	43 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Erythema: Post CYD/Cervarix vaccination 2	41 Participants	34 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Erythema: Post CYD vaccination 3	6 Participants	11 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Swelling: Post any CYD/Cervarix vaccine	73 Participants	60 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Swelling: Post CYD/Cervarix vaccination 1	55 Participants	44 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Swelling: Post CYD/Cervarix vaccination 2	48 Participants	35 Participants
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Swelling: Post CYD vaccination 3	8 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 14 days after any and each vaccination

Population: Analysis was performed on safety analysis set. Here, "number analyzed" signifies participants with available data for specified categories.

Solicited systemic reactions included Fever, Headache, Malaise, Myalgia, and Asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=237 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=241 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Fever: Post any vaccination	25 Participants	35 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Fever: Post vaccination 1 (Visit 1)	14 Participants	8 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Fever: Post CYD vaccination 1 (Visit 2)	—	14 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Fever: Post vaccination 2 (Visit 4)	10 Participants	12 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Fever: Post CYD vaccination 2 (Visit 5)	—	8 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Fever: Post CYD vaccination 3 (Visit 7)	5 Participants	3 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Headache: Post any vaccination	101 Participants	111 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Headache: Post vaccination 1 (Visit 1)	83 Participants	69 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Headache: Post CYD vaccination 1 (Visit 2)	—	54 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Headache: Post vaccination 2 (Visit 4)	47 Participants	48 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Headache: Post CYD vaccination 2 (Visit 5)	—	36 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Headache: Post CYD vaccination 3 (Visit 7)	18 Participants	15 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Malaise: Post any vaccination	113 Participants	133 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Malaise: Post vaccination 1 (Visit 1)	84 Participants	84 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Malaise: Post CYD vaccination 1 (Visit 2)	—	56 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Malaise: Post vaccination 2 (Visit 4)	73 Participants	72 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Malaise: Post CYD vaccination 2 (Visit 5)	—	47 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Malaise: Post CYD vaccination 3 (Visit 7)	19 Participants	28 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Myalgia: Post any vaccination	160 Participants	168 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Myalgia: Post vaccination 1 (Visit 1)	129 Participants	124 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Myalgia: Post CYD vaccination 1 (Visit 2)	—	76 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Myalgia: Post vaccination 2 (Visit 4)	96 Participants	95 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Myalgia: Post CYD vaccination 2 (Visit 5)	—	60 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Myalgia: Post CYD vaccination 3 (Visit 7)	26 Participants	31 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Asthenia: Post any vaccination	93 Participants	95 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Asthenia: Post vaccination 1 (Visit 1)	72 Participants	53 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Asthenia: Post CYD vaccination 1 (Visit 2)	—	47 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Asthenia: Post vaccination 2 (Visit 4)	51 Participants	35 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Asthenia: Post CYD vaccination 2 (Visit 5)	—	30 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine Asthenia: Post CYD vaccination 3 (Visit 7)	16 Participants	13 Participants

SECONDARY outcome

Timeframe: Up to 28 days after any and each vaccination

Population: Analysis was performed on safety analysis set. Here, "number analyzed" signifies participants with available data for specified categories.

An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=237 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=241 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine Post any vaccination	50 Participants	76 Participants
Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine Post vaccination 1 (Visit 1)	33 Participants	37 Participants
Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine Post CYD vaccination 1 (Visit 2)	—	25 Participants
Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine Post vaccination 2 (Visit 4)	26 Participants	23 Participants
Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine Post CYD vaccination 2 (Visit 5)	—	15 Participants
Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine Post CYD vaccination 3 (Visit 7)	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 7 days after any and each vaccination

Population: Analysis was performed on safety analysis set. Here, 'number analyzed' signifies participants with available data for specified categories.

AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=237 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=241 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine Post any CYD/Cervarix vaccination	0 Participants	0 Participants
Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine Post CYD/Cervarix vaccination 1	0 Participants	0 Participants
Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine Post CYD/Cervarix vaccination 2	0 Participants	0 Participants
Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine Post CYD/Cervarix vaccination 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to 6 months after the last CYD or Cervarix vaccination

Population: Analysis was performed on safety analysis set.

An SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. An AESIs were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=237 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=241 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine SAE	6 Participants	0 Participants
Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine Serious AESI	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to 6 months after the last CYD or Cervarix vaccination

Population: Analysis was performed on safety analysis set.

Hospitalized suspected dengue case was defined as an acute febrile illness with diagnosis of dengue requiring hospitalization (with bed attribution). In such cases, 1 unplanned acute blood sample (within the first 5 days after fever onset) was collected for virological confirmation of hospitalized suspected dengue case. A suspected case was considered VCD if there was a detection of wild type dengue virus by dengue non-structural protein 1 antigen ELISA and/or dengue reverse transcriptase-polymerase chain reactions.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=237 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=241 Participants Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix or CYD Dengue Vaccine	0 Participants	0 Participants

Adverse Events

CYD Dengue Vaccine + Cervarix (Sequential Administration)

Serious events: 6 serious events

Other events: 222 other events

Deaths: 0 deaths

CYD Dengue Vaccine + Cervarix (Concomitant Administration)

Serious events: 0 serious events

Other events: 228 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=237 participants at risk Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=241 participants at risk Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
Infections and infestations Appendicitis	0.42% 1/237 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	0.00% 0/241 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
Injury, poisoning and procedural complications Forearm Fracture	0.42% 1/237 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	0.00% 0/241 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
Injury, poisoning and procedural complications Gun Shot Wound	0.42% 1/237 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	0.00% 0/241 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
Injury, poisoning and procedural complications Radius Fracture	0.42% 1/237 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	0.00% 0/241 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
Pregnancy, puerperium and perinatal conditions Pre-Eclampsia	0.42% 1/237 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	0.00% 0/241 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
Renal and urinary disorders Nephrolithiasis	0.42% 1/237 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	0.00% 0/241 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.

Other adverse events

Other adverse events
Measure	CYD Dengue Vaccine + Cervarix (Sequential Administration) n=237 participants at risk Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.	CYD Dengue Vaccine + Cervarix (Concomitant Administration) n=241 participants at risk Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
General disorders Asthenia	39.2% 93/237 • Number of events 139 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	39.4% 95/241 • Number of events 178 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
General disorders Injection Site Erythema	27.0% 64/237 • Number of events 137 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	25.3% 61/241 • Number of events 116 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
General disorders Injection Site Pain	89.5% 212/237 • Number of events 659 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	91.7% 221/241 • Number of events 628 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
General disorders Injection Site Swelling	30.8% 73/237 • Number of events 154 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	24.9% 60/241 • Number of events 115 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
General disorders Malaise	47.7% 113/237 • Number of events 176 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	55.2% 133/241 • Number of events 287 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
General disorders Pyrexia	10.5% 25/237 • Number of events 29 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	15.4% 37/241 • Number of events 47 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
Infections and infestations Nasopharyngitis	3.4% 8/237 • Number of events 9 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	9.1% 22/241 • Number of events 26 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
Infections and infestations Pharyngitis	5.5% 13/237 • Number of events 13 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	8.3% 20/241 • Number of events 21 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
Musculoskeletal and connective tissue disorders Myalgia	67.5% 160/237 • Number of events 251 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	69.7% 168/241 • Number of events 386 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.
Nervous system disorders Headache	43.0% 102/237 • Number of events 149 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.	46.9% 113/241 • Number of events 227 • AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination. The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.

Additional Information

Trial Transparency Team

Sanofi Pasteur

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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.
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