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

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil® in Healthy Subjects Aged 9 to 13 Years in Malaysia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02993757

Enrollment

528

Registered

2016-12-15

Start date

2016-12-01

Completion date

2019-05-27

Last updated

2022-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue Fever, Dengue Hemorrhagic Fever, Human Papillomavirus Disease

Keywords

Dengue Fever, Dengue Hemorrhagic Fever, Human Papillomavirus Disease, CYD Dengue Vaccine, Dengvaxia®, Gardasil®

Brief summary

The aim of the study was to assess the safety and immunogenicity of the CYD dengue vaccine and Gardasil (Human Papillomavirus Quadrivalent \[Types 6, 11, 16, and 18\] Vaccine, Recombinant) when administered concomitantly or sequentially. Primary objectives: * To demonstrate that the humoral immune response (in terms of geometric mean titers \[GMTs\]) to Gardasil after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil. * To demonstrate that the humoral immune response to the CYD dengue vaccine after concomitant administration was non-inferior to sequential administration with Gardasil measured 28 days after the last dose of the CYD dengue vaccine. Secondary Objectives: * To demonstrate that the humoral immune response (in terms of seroconversion) to Gardasil vaccine after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil. * To describe the humoral immune response to Gardasil at baseline and after each dose of Gardasil in each and any group. * To describe the humoral immune response to the CYD dengue vaccine at baseline and after each dose of the CYD dengue vaccine in each and any group. * To describe the safety of Gardasil and the CYD dengue vaccine after each and any dose in each group.

Detailed description

Participants received 3 doses of CYD dengue vaccine and 2 doses of Gardasil administered either concomitantly or sequentially. The study activities were put on hold for several months (up to 6 months for some participants) to obtain the approval of Protocol Amendment 1 by the competent authorities and completed the associated logistic tasks. Due to this protocol amendment as per Independent Data Monitoring Committee recommendation, only previously dengue immune participants (seropositive for dengue before vaccination) were eligible to complete the vaccination schedule. Dengue non-immune participants (seronegative for dengue before vaccination) did not receive any additional CYD dengue vaccine injections, but were followed for safety up to 6 months after the last injection. Due to the change in amendment 1, the number of evaluable dengue immune participants at baseline did not meet the predefined number of participants that would have allowed for a global power of at least 80% for non-inferiority testing of Gardasil vaccine and CYD dengue vaccine (121 per group for the co-primary objectives and 194 per group for the secondary objectives). All participants were assessed for immunogenicity and safety. Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events (AEs) within 28 days after each injection, non-serious AEs of Special Interests (AESIs) within 7 days after each injection, and serious adverse events including AESI and hospitalized virologically-confirmed dengue cases during the study period.

Interventions

BIOLOGICALCYD Dengue Vaccine

0.5 mL, SC injection at Day 0, Month 6 and 12, respectively.

BIOLOGICALHuman Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant.

0.5 mL, IM injection at Day 0 and Month 6, respectively.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

9 Years to 13 Years

Healthy volunteers

Yes

Inclusion criteria

* Participants aged 9 to 13 years (i.e., from the day of the 9th birthday to the day prior to the 14th birthday) on the day of inclusion. * Informed consent form (ICF) or Assent form (AF) had been signed and dated by the participant (based on local regulations), and/or ICF had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations). * Participant (or participant and parent\[s\] or another legally acceptable representative) was (were) able to attend all scheduled visits and complied with all trial procedures. * Participant in good health, based on medical history, and physical examination.

Exclusion criteria

* Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female had to be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination). * Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Planned receipt of any vaccine in the 4 weeks following any trial vaccination. * Previous vaccination against dengue disease with the trial vaccine. * Previous vaccination against human papillomavirus (HPV) disease with either the trial vaccine or another vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency (including human immunodeficiency virus infection with impaired immune function); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * History of HPV infection, confirmed either clinically, serologically, or microbiologically as reported by participant or parent(s) or another legally acceptable representative. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * Thrombocytopenia, contraindicating IM vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction that, based on investigator's judgment, might interfered with the participant's ability to comply with trial procedures. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfered with trial conduct or completion. * Identified as an Investigator or employee of the Investigator with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. * Self-reported Hepatitis B, Hepatitis C infection.

Design outcomes

Primary

Measure	Time frame	Description
Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants	28 days after the last Gardasil vaccination	GMTs (measured in milli-Merck Units per mL \[mMU/mL\]) against each Gardasil HPV antigen (HPV-6, HPV-11, HPV-16, HPV-18) were assessed using competitive Luminex immunoassay (cLIA) method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strains.
Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants	28 days after third CYD dengue vaccination	The GMTs against each of the four parental dengue virus serotypes (1, 2, 3, and 4) of CYD dengue vaccine was assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strains.

Secondary

Measure	Time frame	Description
Geometric Mean Titers 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 Immune Participants	Day 0 (pre-vaccination) and 28 days after each CYD dengue vaccination	The GMTs against each of the four parental dengue virus serotypes (1, 2, 3, and 4) of CYD dengue vaccine was assessed using the PRNT50 assay. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strains.
Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Day 0 (pre-vaccination) and 28 days after each CYD dengue vaccination	Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (1, 2, 3, and 4) was measured by PRNT50. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strains.
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	Day 0 (pre-vaccination) and 28 days after each CYD dengue vaccination	Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (1, 2, 3, and 4) was measured by PRNT50. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strains. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (\>=10 and \>=100 \[1/dil\]) against at least 1, 2, 3, or 4 serotypes of CYD dengue vaccine were reported.
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Within 30 minutes after any and each vaccination	Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE. At Visit 1 and Visit 4, participants from Group 1 received both Gardasil and CYD vaccination and participants from Group 2 received only Gardasil vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Up to 7 days after any and each vaccination	A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema, and swelling.
Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants	28 days after the last Gardasil vaccination	Neutralizing antibodies against each Gardasil HPV antigen (HPV-6, HPV-11, HPV-16, HPV-18) was assessed using cLIA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (participants with a pre-vaccination titer \< lower limit of quantification \[LLOQ\] (mMU/mL) to a post-vaccination titer \>=LLOQ) or \>=4-fold rise in antibody titer if seropositive at baseline. The LLOQ for HPV-6 and HPV-16 was 11 mMU/mL, 8 mMU/mL for HPV-11, and 10 mMU/mL for HPV-18. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strains.
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Up to 28 days after any and each vaccination	An unsolicited AE was an observed AE that did 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 Gardasil and CYD vaccination and participants from Group 2 received only Gardasil vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.
Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Within 7 days after any and each vaccination	AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. At Visit 1 and Visit 4, participants from Group 1 received both Gardasil and CYD vaccination and participants from Group 2 received only Gardasil vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.
Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious Adverse Event of Special Interests Following Vaccination With Gardasil or CYD Dengue Vaccine	From Day 0 up to 6 months after the last Gardasil or CYD vaccination	SAEs were AEs that resulted 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.
Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Gardasil or CYD Dengue Vaccine	From Day 0 up to 6 months after the last Gardasil or CYD vaccination	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 enzyme-linked immunosorbent assay and/or dengue reverse transcriptase-polymerase chain reactions.
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Up to 14 days after any and each vaccination	A SR was an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise, myalgia, and asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Gardasil and CYD vaccination and participants from Group 2 received only Gardasil vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.
Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	Day 0 (pre-vaccination) and 28 days after Gardasil vaccination 1 and 2	The GMTs (measured in mMU/mL) against each Gardasil HPV antigen (HPV-6, HPV-11, HPV-16, HPV-18) was assessed using cLIA method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strains.

Countries

Malaysia

Participant flow

Recruitment details

Study participants were enrolled from 01 December 2016 to 16 April 2017 at 5 centers in Malaysia. A total of 528 participants were enrolled and randomized in study.

Pre-assignment details

As per protocol amendment 1, only dengue immune participants at baseline completed the dengue vaccination schedule and received 3 doses of CYD dengue vaccine, whereas the dengue non-immune participants received only 2 doses of CYD dengue vaccine. All participants were followed for safety up to 6 months after the last vaccination.

Participants by arm

Arm	Count
CYD Dengue Vaccine + Gardasil (Concomitant Administration) Dengue immune participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12; whereas dengue non-immune participants received only 2 doses of CYD vaccine at Day 0 and Month 6. Both immune and non-immune participants received 2 doses of Gardasil vaccine 0.5 mL IM, concomitantly with the first 2 doses of CYD dengue vaccine.	266
CYD Dengue Vaccine + Gardasil (Sequential Administration) Dengue immune participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13; whereas dengue non-immune participants received only 2 doses of CYD vaccine at Month 1 and Month 7. Both immune and non-immune participants received 2 doses of Gardasil vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the first 2 doses of CYD dengue vaccine.	262
Total	528

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0
Overall Study	Non compliance with the protocol	155	170
Overall Study	Voluntary withdraw not due adverse event	8	8

Baseline characteristics

Characteristic	CYD Dengue Vaccine + Gardasil (Sequential Administration)	Total	CYD Dengue Vaccine + Gardasil (Concomitant Administration)
Age, Continuous	10.5 years STANDARD_DEVIATION 1.18	10.4 years STANDARD_DEVIATION 1.19	10.4 years STANDARD_DEVIATION 1.2
Dengue Seropositivity Status Dengue immune	88 Participants	197 Participants	109 Participants
Dengue Seropositivity Status Dengue non-immune	174 Participants	331 Participants	157 Participants
Race and Ethnicity Not Collected	—	0 Participants	—
Sex: Female, Male Female	172 Participants	347 Participants	175 Participants
Sex: Female, Male Male	90 Participants	181 Participants	91 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 263	0 / 260
other Total, other adverse events	233 / 263	235 / 260
serious Total, serious adverse events	11 / 263	8 / 260

Outcome results

Primary

Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants

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

Time frame: 28 days after third CYD dengue vaccination

Population: Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants evaluable and had available data for this outcome measure.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants	Serotype 1	447 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants	Serotype 2	561 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants	Serotype 3	460 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants	Serotype 4	323 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants	Serotype 4	303 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants	Serotype 1	453 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants	Serotype 3	549 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants	Serotype 2	717 titer (1/dilution)

Comparison: Serotype 195% CI: [0.574, 1.7]

Comparison: Serotype 295% CI: [0.5, 1.22]

Comparison: Serotype 395% CI: [0.568, 1.23]

Comparison: Serotype 495% CI: [0.813, 1.4]

Primary

Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants

GMTs (measured in milli-Merck Units per mL \[mMU/mL\]) against each Gardasil HPV antigen (HPV-6, HPV-11, HPV-16, HPV-18) were assessed using competitive Luminex immunoassay (cLIA) method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strains.

Time frame: 28 days after the last Gardasil vaccination

Population: Analysis was performed on full analysis set (FAS) that included subset of participants who received at least one dose of each of study vaccines (CYD and Gardasil), analyzed by baseline dengue status \& vaccine group randomized. Here,'overall number of participants analyzed' = participants evaluable and had available data for this outcome measure.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants	HPV-6	420 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants	HPV-11	1288 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants	HPV-16	6221 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants	HPV-18	829 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants	HPV-18	1042 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants	HPV-6	428 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants	HPV-16	7629 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants	HPV-11	1601 mMU/mL

Comparison: Antigen HPV-695% CI: [0.664, 1.45]

Comparison: Antigen HPV-1195% CI: [0.626, 1.03]

Comparison: Antigen HPV-1695% CI: [0.608, 1.09]

Comparison: Antigen HPV-1895% CI: [0.603, 1.05]

Secondary

Geometric Mean Titers 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 Immune Participants

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

Time frame: Day 0 (pre-vaccination) and 28 days after each CYD dengue vaccination

Population: Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants evaluable and had available data for this outcome measure and 'Number analyzed' = participants with available data for each specified categories.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 1: Day 0	62.3 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 1	382 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 2	403 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 3	447 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 2: Day 0	110 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 1	750 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 2	728 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 3	561 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 3: Day 0	72.3 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 1	432 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 2	389 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 3	460 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 4: Day 0	26.3 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 1	330 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 2	284 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 3	323 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 3	303 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 1: Day 0	81.5 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 3: Day 0	96.7 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 1	449 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 4: Day 0	23.7 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 2	529 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 1	517 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 3	453 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 2	282 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 2: Day 0	130 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 2	543 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 1	848 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 1	286 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 2	937 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 3	549 titer (1/dilution)
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 3	717 titer (1/dilution)

Secondary

Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants

The GMTs (measured in mMU/mL) against each Gardasil HPV antigen (HPV-6, HPV-11, HPV-16, HPV-18) was assessed using cLIA method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strains.

Time frame: Day 0 (pre-vaccination) and 28 days after Gardasil vaccination 1 and 2

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-6: Day 0	5.70 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-6: 28 days post vaccination 1	54.9 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-6: 28 days post vaccination 2	420 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-11: Day 0	4.16 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-11: 28 days post vaccination 1	58.1 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-11: 28 days post vaccination 2	1288 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-16: Day 0	5.62 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-16: 28 days post vaccination 1	148 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-16: 28 days post vaccination 2	6221 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-18: Day 0	5.26 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-18: 28 days post vaccination 1	23.5 mMU/mL
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-18: 28 days post vaccination 2	829 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-18: 28 days post vaccination 1	31.6 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-6: Day 0	5.61 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-16: Day 0	5.50 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-6: 28 days post vaccination 1	61.8 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-18: Day 0	5.06 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-6: 28 days post vaccination 2	428 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-16: 28 days post vaccination 1	150 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-11: Day 0	4.00 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-18: 28 days post vaccination 2	1042 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-11: 28 days post vaccination 1	78.5 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-16: 28 days post vaccination 2	7629 mMU/mL
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants	HPV-11: 28 days post vaccination 2	1601 mMU/mL

Secondary

Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Gardasil or CYD Dengue Vaccine

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 enzyme-linked immunosorbent assay and/or dengue reverse transcriptase-polymerase chain reactions.

Time frame: From Day 0 up to 6 months after the last Gardasil or CYD vaccination

Population: Analysis was performed on SafAS.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Gardasil or CYD Dengue Vaccine	1 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Gardasil or CYD Dengue Vaccine	1 Participants

Secondary

Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine

Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE. At Visit 1 and Visit 4, participants from Group 1 received both Gardasil and CYD vaccination and participants from Group 2 received only Gardasil vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.

Time frame: Within 30 minutes after any and each vaccination

Population: Analysis was performed on safety analysis set (SafAS) which included participants who have received at least one dose of the study vaccines. Here, 'Number analyzed' = participants with available data for each specified categories.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 1 (Visit 1)	0 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post any vaccination	0 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 2 (Visit 4)	0 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 3 (Visit 7)	0 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 1 (Visit 2)	1 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 3 (Visit 7)	0 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 2 (Visit 4)	0 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 2 (Visit 5)	1 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post any vaccination	3 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 1 (Visit 1)	1 Participants

Secondary

Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine

AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. At Visit 1 and Visit 4, participants from Group 1 received both Gardasil and CYD vaccination and participants from Group 2 received only Gardasil vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.

Time frame: Within 7 days after any and each vaccination

Population: Analysis was performed on SafAS. Here, 'Number analyzed' = participants with available data for each specified categories.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post any vaccination	0 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 1 (Visit 1)	0 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 2 (Visit 4)	0 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 3 (Visit 7)	0 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 1 (Visit 2)	0 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 3 (Visit 7)	0 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 2 (Visit 4)	0 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post any vaccination	0 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 2 (Visit 5)	0 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 1 (Visit 1)	0 Participants

Secondary

Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious Adverse Event of Special Interests Following Vaccination With Gardasil or CYD Dengue Vaccine

SAEs were AEs that resulted 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.

Time frame: From Day 0 up to 6 months after the last Gardasil or CYD vaccination

Population: Analysis was performed on SafAS.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious Adverse Event of Special Interests Following Vaccination With Gardasil or CYD Dengue Vaccine	SAE	11 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious Adverse Event of Special Interests Following Vaccination With Gardasil or CYD Dengue Vaccine	Serious AESI	1 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious Adverse Event of Special Interests Following Vaccination With Gardasil or CYD Dengue Vaccine	SAE	8 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious Adverse Event of Special Interests Following Vaccination With Gardasil or CYD Dengue Vaccine	Serious AESI	2 Participants

Secondary

Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine

A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema, and swelling.

Time frame: Up to 7 days after any and each vaccination

Population: Analysis was performed on SafAS. Here, 'Number analyzed' = participants with available data for each specified categories.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Pain: Post CYD/Gardasil vaccination 1	163 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Erythema: Post CYD/Gardasil vaccination 2	25 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Pain: Post CYD vaccination 3	33 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Erythema: Post CYD vaccination 3	9 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Pain: Post any CYD/Gardasil vaccine	206 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Swelling: Post any CYD/Gardasil vaccine	43 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Erythema: Post any CYD/Gardasil vaccine	45 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Swelling: Post CYD/Gardasil vaccination 1	22 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Pain: Post CYD/Gardasil vaccination 2	151 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Swelling: Post CYD/Gardasil vaccination 2	30 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Swelling: Post CYD vaccination 3	9 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Erythema: Post CYD/Gardasil vaccination 1	30 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Swelling: Post CYD vaccination 3	3 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Pain: Post any CYD/Gardasil vaccine	193 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Pain: Post CYD/Gardasil vaccination 1	157 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Pain: Post CYD/Gardasil vaccination 2	141 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Pain: Post CYD vaccination 3	24 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Erythema: Post any CYD/Gardasil vaccine	38 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Erythema: Post CYD/Gardasil vaccination 1	29 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Erythema: Post CYD/Gardasil vaccination 2	19 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Erythema: Post CYD vaccination 3	2 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Swelling: Post any CYD/Gardasil vaccine	31 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Swelling: Post CYD/Gardasil vaccination 1	22 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Swelling: Post CYD/Gardasil vaccination 2	18 Participants

Secondary

Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine

A SR was an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise, myalgia, and asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Gardasil and CYD vaccination and participants from Group 2 received only Gardasil vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.

Time frame: Up to 14 days after any and each vaccination

Population: Analysis was performed on SafAS. Here, 'Number analyzed' = participants with available data for each specified categories.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Myalgia: Post any vaccination	127 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Headache: Post vaccination 1 (Visit 1)	99 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Myalgia: Post vaccination 1 (Visit 1)	93 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Malaise: Post any vaccination	111 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Fever: Post CYD vaccination 3 (Visit 7)	8 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Myalgia: Post vaccination 2 (Visit 4)	72 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Malaise: Post vaccination 1 (Visit 1)	82 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Fever: Post vaccination 1 (Visit 1)	21 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Myalgia: Post CYD vaccination 3 (Visit 7)	16 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Headache: Post vaccination 2 (Visit 4)	61 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Asthenia: Post any vaccination	133 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Malaise: Post vaccination 2 (Visit 4)	57 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Asthenia: Post vaccination 1 (Visit 1)	101 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Headache: Post any vaccination	125 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Fever: Post vaccination 2 (Visit 4)	10 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Asthenia: Post vaccination 2 (Visit 4)	74 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Malaise: Post CYD vaccination 3 (Visit 7)	20 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Headache: Post CYD vaccination 3 (Visit 7)	15 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Asthenia: Post CYD vaccination 3 (Visit 7)	19 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Fever: Post any vaccination	36 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Myalgia: Post vaccination 1 (Visit 1)	94 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Myalgia: Post CYD vaccination 1 (Visit 2)	63 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Myalgia: Post vaccination 2 (Visit 4)	70 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Myalgia: Post CYD vaccination 2 (Visit 5)	43 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Myalgia: Post CYD vaccination 3 (Visit 7)	13 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Asthenia: Post any vaccination	132 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Asthenia: Post vaccination 1 (Visit 1)	89 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Asthenia: Post CYD vaccination 1 (Visit 2)	63 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Asthenia: Post vaccination 2 (Visit 4)	46 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Asthenia: Post CYD vaccination 2 (Visit 5)	35 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Asthenia: Post CYD vaccination 3 (Visit 7)	16 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Fever: Post any vaccination	47 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Fever: Post vaccination 1 (Visit 1)	8 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Fever: Post CYD vaccination 1 (Visit 2)	15 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Fever: Post vaccination 2 (Visit 4)	11 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Fever: Post CYD vaccination 2 (Visit 5)	12 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Fever: Post CYD vaccination 3 (Visit 7)	6 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Headache: Post any vaccination	146 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Headache: Post vaccination 1 (Visit 1)	93 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Headache: Post CYD vaccination 1 (Visit 2)	73 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Headache: Post vaccination 2 (Visit 4)	70 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Headache: Post CYD vaccination 2 (Visit 5)	51 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Headache: Post CYD vaccination 3 (Visit 7)	17 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Malaise: Post any vaccination	137 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Malaise: Post vaccination 1 (Visit 1)	78 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Malaise: Post CYD vaccination 1 (Visit 2)	69 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Malaise: Post vaccination 2 (Visit 4)	54 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Malaise: Post CYD vaccination 2 (Visit 5)	40 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Malaise: Post CYD vaccination 3 (Visit 7)	17 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine	Myalgia: Post any vaccination	156 Participants

Secondary

Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine

An unsolicited AE was an observed AE that did 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 Gardasil and CYD vaccination and participants from Group 2 received only Gardasil vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.

Time frame: Up to 28 days after any and each vaccination

Population: Analysis was performed on SafAS. Here, 'Number analyzed' = participants with available data for each specified categories.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Post any vaccination	54 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 1 (Visit 1)	34 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 2 (Visit 4)	24 Participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 3 (Visit 7)	5 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 1 (Visit 2)	38 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 3 (Visit 7)	7 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 2 (Visit 4)	22 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Post any vaccination	91 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Post CYD vaccination 2 (Visit 5)	28 Participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine	Post vaccination 1 (Visit 1)	38 Participants

Secondary

Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants

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

Time frame: Day 0 (pre-vaccination) and 28 days after each CYD dengue vaccination

Arm	Measure	Group	Value (NUMBER)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2 Serotypes: Day 0: >=10 (1/dil)	84.4 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype: Day 0: >=100 (1/dil)	90.8 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination 1:>=10(1/dil)	97.2 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination1:>=100(1/dil)	95.3 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination 2:>=10(1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination2:>=100(1/dil)	96.2 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination 3:>=10(1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination3:>=100(1/dil)	98.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype: Day 0: >=10 (1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2 Serotypes: Day 0: >=100 (1/dil)	34.9 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2 Serotypes:post vaccination1:>=10(1/dil)	94.4 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2Serotypes:post vaccination1:>=100(1/dil)	85.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2 Serotypes:post vaccination2:>=10(1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2Serotypes:post vaccination2:>=100(1/dil)	84.6 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2 Serotypes:post vaccination3:>=10(1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2Serotypes:post vaccination3:>=100(1/dil)	93.1 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3 Serotypes:Day 0: >=10 (1/dil)	71.6 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3 Serotypes:Day 0: >=100 (1/dil)	23.9 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3 Serotypes:post vaccination1:>=10(1/dil)	92.5 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3Serotypes:post vaccination1:>=100(1/dil)	75.7 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3 Serotypes:post vaccination2:>=10(1/dil)	99.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3Serotypes:post vaccination2:>=100(1/dil)	77.9 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3 Serotypes:post vaccination3:>=10(1/dil)	97.1 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3Serotypes:post vaccination3:>=100(1/dil)	83.3 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4 Serotypes:Day 0: >=10 (1/dil)	42.2 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4 Serotypes:Day 0: >=100 (1/dil)	6.4 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4 Serotypes:post vaccination1:>=10(1/dil)	90.6 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4Serotypes:post vaccination1:>=100(1/dil)	60.4 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4 Serotypes:post vaccination2:>=10(1/dil)	96.2 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4Serotypes:post vaccination2:>=100(1/dil)	67.3 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4 Serotypes:post vaccination3:>=10(1/dil)	94.1 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4Serotypes:post vaccination3:>=100(1/dil)	72.5 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4Serotypes:post vaccination3:>=100(1/dil)	77.4 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype: Day 0: >=10 (1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3 Serotypes:Day 0: >=10 (1/dil)	69.3 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype: Day 0: >=100 (1/dil)	88.6 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4 Serotypes:Day 0: >=10 (1/dil)	43.7 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination 1:>=10(1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3 Serotypes:Day 0: >=100 (1/dil)	27.3 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination1:>=100(1/dil)	96.6 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4 Serotypes:post vaccination2:>=10(1/dil)	94.3 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination 2:>=10(1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3 Serotypes:post vaccination1:>=10(1/dil)	92.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination2:>=100(1/dil)	98.9 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4 Serotypes:Day 0: >=100 (1/dil)	12.6 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination 3:>=10(1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3Serotypes:post vaccination1:>=100(1/dil)	73.9 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 1 Serotype:post vaccination3:>=100(1/dil)	97.6 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4 Serotypes:post vaccination3:>=10(1/dil)	98.8 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2 Serotypes: Day 0: >=10 (1/dil)	81.8 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3 Serotypes:post vaccination2:>=10(1/dil)	98.9 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2 Serotypes: Day 0: >=100 (1/dil)	39.8 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4 Serotypes:post vaccination1:>=10(1/dil)	89.8 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2 Serotypes:post vaccination1:>=10(1/dil)	97.7 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3Serotypes:post vaccination2:>=100(1/dil)	86.2 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2Serotypes:post vaccination1:>=100(1/dil)	80.7 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4Serotypes:post vaccination2:>=100(1/dil)	75.9 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2 Serotypes:post vaccination2:>=10(1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3 Serotypes:post vaccination3:>=10(1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2Serotypes:post vaccination2:>=100(1/dil)	92.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 4Serotypes:post vaccination1:>=100(1/dil)	62.5 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2 Serotypes:post vaccination3:>=10(1/dil)	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 3Serotypes:post vaccination3:>=100(1/dil)	88.1 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants	At least 2Serotypes:post vaccination3:>=100(1/dil)	94.0 percentage of participants

Secondary

Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants

Time frame: Day 0 (pre-vaccination) and 28 days after each CYD dengue vaccination

Arm	Measure	Group	Value (NUMBER)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 1: Day 0	66.1 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 3: Day 0	89.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 2: Day 0	83.5 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 1	96.2 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 2	96.2 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 2	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 1	93.5 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 3	99.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 1	91.6 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 4: Day 0	59.6 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 2	99.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 1	93.5 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 2	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 3	95.1 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 3	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 3	97.1 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 3	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 1: Day 0	72.7 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 1	90.9 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 2	95.4 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 1: 28 days post vaccination 3	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 2: Day 0	81.8 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 1	92.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 2	97.7 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 2: 28 days post-vaccination 3	98.8 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 3: Day 0	86.2 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 1	97.7 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 2	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 3: 28 days post-vaccination 3	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 4: Day 0	54.5 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 2	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants	Serotype 4: 28 days post-vaccination 1	98.9 percentage of participants

Secondary

Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants

Neutralizing antibodies against each Gardasil HPV antigen (HPV-6, HPV-11, HPV-16, HPV-18) was assessed using cLIA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (participants with a pre-vaccination titer \< lower limit of quantification \[LLOQ\] (mMU/mL) to a post-vaccination titer \>=LLOQ) or \>=4-fold rise in antibody titer if seropositive at baseline. The LLOQ for HPV-6 and HPV-16 was 11 mMU/mL, 8 mMU/mL for HPV-11, and 10 mMU/mL for HPV-18. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strains.

Time frame: 28 days after the last Gardasil vaccination

Population: Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants evaluable and had available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants	HPV-6	98.1 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants	HPV-11	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants	HPV-16	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Concomitant Administration)	Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants	HPV-18	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants	HPV-18	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants	HPV-6	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants	HPV-16	100.0 percentage of participants
CYD Dengue Vaccine + Gardasil (Sequential Administration)	Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants	HPV-11	100.0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants

Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants

Geometric Mean Titers 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 Immune Participants

Geometric Mean Titers Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) at Day 0 and 28 Days After Each Dose of Gardasil in the Previously Dengue Immune Participants

Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Gardasil or CYD Dengue Vaccine

Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Gardasil or CYD Dengue Vaccine

Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Gardasil or CYD Dengue Vaccine

Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious Adverse Event of Special Interests Following Vaccination With Gardasil or CYD Dengue Vaccine

Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine

Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Gardasil or CYD Dengue Vaccine

Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Gardasil or CYD Dengue Vaccine

Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against at Least 1,2,3,or4 Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Immune Participants

Percentage of Participants With Neutralizing Antibody Titers 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 Immune Participants

Percentage of Participants With Seroconversion Against Each Gardasil HPV Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Dose of Gardasil in the Previously Dengue Immune Participants