Dengue Fever, Dengue Hemorrhagic Fever, Human Papillomavirus Disease
Conditions
Keywords
Dengue Fever, Dengue Hemorrhagic Fever, Human Papillomavirus Disease, CYD Dengue Vaccine, Dengvaxia®, Cervarix®
Brief summary
The aim of this study was to investigate the immunogenicity and safety of CYD dengue vaccine and Cervarix when administered concomitantly or sequentially in healthy female participants aged 9-14 years of age. Primary objectives: * To demonstrate that the humoral immune response (in terms of geometric mean titers \[GMTs\]) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of GMTs) after sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix. * To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after concomitant administration with Cervarix is non-inferior to the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after sequential administration with Cervarix 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 Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of seroconversion) to Cervarix sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix. * To describe the humoral immune response to Cervarix at baseline and after each dose of Cervarix 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 Cervarix and CYD dengue vaccine after each and any dose in each group.
Detailed description
Participants received 3 doses of the CYD dengue vaccine and 2 doses of Cervarix administered either concomitantly or sequentially. Due to a protocol amendment, only previously dengue exposed participants (seropositive for dengue before vaccination) were eligible to complete the vaccination schedule and be assessed for CYD immunogenicity and human papilloma virus (HPV) immunogenicity. Dengue unexposed participants (seronegative for dengue before vaccination) did not receive the third CYD dengue vaccine injection, but were followed for safety up to 6 months after the last injection. Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period. All participants were included in the assessment of safety up to 6 months after the last injection.
Interventions
BIOLOGICALCYD Dengue Vaccine
0.5 mL, SC at Day 0, Months 6 and 12
BIOLOGICALHuman Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant
0.5 mL, IM at Day 0 and Month 6
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Female aged 9 to 14 years (i.e., from the day of the 9th birthday to the day prior to the 15th 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 must 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 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 HIV 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 interfere 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 interfere 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 Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants | 28 days after the last Cervarix vaccination | GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an enzyme-linked immunosorbent assay (ELISA) method. Dengue seropositive participants at baseline were defined as those participants with titers greater than or equal to (\>=) 10 (1/dilutions \[dil\]) for at least one serotype with the parental dengue virus strain. |
| GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | 28 days after third CYD dengue vaccination | The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Day 0 and 28 days after each CYD dengue vaccine vaccination | The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the PRNT50 assay. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain. |
| Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Day 0 and 28 days after each CYD dengue vaccine vaccination | Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain. |
| Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | Day 0 and 28 days after each CYD dengue vaccination | Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain. |
| Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Day 0 and 28 days after each CYD dengue vaccination | Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (\<10, \>=10 and \>=100 \[1/dil\]) against each dengue virus serotypes of CYD were reported. |
| Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Within 30 minutes after each and any vaccination | Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE. |
| GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | Day 0 and 28 days after each Cervarix vaccination | The GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain. |
| Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Up to 14 days after any and each vaccination | Solicited systemic reactions included Fever, Headache, Malaise, Myalgia, and Asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination. |
| Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Up to 28 days after any and each vaccination | An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination. |
| Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Up to 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. |
| Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine | From Day 0 up to 6 months after the last CYD or Cervarix vaccination | An SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. An AESIs were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. |
| Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix or CYD Dengue Vaccine | From Day 0 up to 6 months after the last CYD or Cervarix 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 ELISA and/or dengue reverse transcriptase-polymerase chain reactions. |
| Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Up to 7 days after each and any vaccination | Solicited injection site reactions included pain, erythema, and swelling. |
| Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants | 28 days after each Cervarix vaccination | Neutralizing antibodies against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (greater than \[\>\] lower limit of quantitation \[LLOQ\] of the assay) or \>=4-fold rise in antibody titer if seropositive at baseline (i.e., at least one antibody levels against Cervarix HPV antigens \> LLOQ at baseline). The LLOQ for HPV-16 and HPV-18 was less than (\<) 2.0 International Units per milliliter (IU/mL). |
Countries
Mexico
Participant flow
Recruitment details
Study participants were enrolled from 16 November 2016 to 13 March 2017 at 3 centers in Mexico.
Pre-assignment details
A total of 480 participants were enrolled and randomized in this study.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine. | 239 |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine. | 241 |
| Total | 480 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent withdrawn by participant | 11 | 18 |
| Overall Study | Lost to Follow-up | 6 | 1 |
| Overall Study | Non compliance with the protocol | 78 | 82 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine + Cervarix (Concomitant Administration) | CYD Dengue Vaccine + Cervarix (Sequential Administration) | Total |
|---|---|---|---|
| Age, Continuous | 9.50 years STANDARD_DEVIATION 1 | 9.56 years STANDARD_DEVIATION 1.05 | 9.53 years STANDARD_DEVIATION 1.03 |
| Race/Ethnicity, Customized Race: Not reported | 239 Participants | 241 Participants | 480 Participants |
| Sex: Female, Male Female | 239 Participants | 241 Participants | 480 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 237 | 0 / 241 |
| other Total, other adverse events | 222 / 237 | 228 / 241 |
| serious Total, serious adverse events | 6 / 237 | 0 / 241 |
Outcome results
Primary
Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants
GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an enzyme-linked immunosorbent assay (ELISA) method. Dengue seropositive participants at baseline were defined as those participants with titers greater than or equal to (\>=) 10 (1/dilutions \[dil\]) for at least one serotype with the parental dengue virus strain.
Time frame: 28 days after the last Cervarix vaccination
Population: Analysis was performed on per-protocol analysis set (PPS) for Cervarix which included participants who received at least one dose of Cervarix vaccine and had no relevant protocol deviations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16 | 2149 Endotoxin Units per milliliter (EU/mL) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18 | 833 Endotoxin Units per milliliter (EU/mL) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16 | 2268 Endotoxin Units per milliliter (EU/mL) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18 | 845 Endotoxin Units per milliliter (EU/mL) |
Comparison: Antigen HPV-1695% CI: [0.773, 1.16]
Comparison: Antigen HPV-1895% CI: [0.803, 1.21]
Primary
GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants
The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.
Time frame: 28 days after third CYD dengue vaccination
Population: Analysis was performed on the full analysis set (FAS) which was defined as the subset of participants who received at least one dose of the study vaccine. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2 | 670 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1 | 384 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3 | 357 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4 | 247 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4 | 265 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2 | 735 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3 | 388 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1 | 393 titer (1/dilution) |
Comparison: Dengue Virus Serotype 195% CI: [0.653, 1.46]
Comparison: Dengue Virus Serotype 295% CI: [0.654, 1.27]
Comparison: Dengue Virus Serotype 395% CI: [0.727, 1.17]
Comparison: Dengue Virus Serotype 495% CI: [0.733, 1.18]
Secondary
GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants
The GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.
Time frame: Day 0 and 28 days after each Cervarix vaccination
Population: Analysis was performed on FAS population. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16: Day 0 | 1.61 EU/mL |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16: 28 days post vaccination 1 | 118 EU/mL |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16: 28 days post vaccination 2 | 2089 EU/mL |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18: Day 0 | 1.34 EU/mL |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18: 28 days post vaccination 1 | 53.8 EU/mL |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18: 28 days post vaccination 2 | 846 EU/mL |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18: 28 days post vaccination 1 | 68.6 EU/mL |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16: Day 0 | 1.58 EU/mL |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18: Day 0 | 1.34 EU/mL |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16: 28 days post vaccination 1 | 140 EU/mL |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18: 28 days post vaccination 2 | 846 EU/mL |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16: 28 days post vaccination 2 | 2162 EU/mL |
Secondary
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants
The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the PRNT50 assay. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.
Time frame: Day 0 and 28 days after each CYD dengue vaccine vaccination
Population: Analysis was performed on FAS population. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified categories.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 2 | 460 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: Day 0 | 150 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 1 | 711 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 3 | 384 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: Day 0 | 193 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 1 | 1168 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 2 | 618 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 3 | 670 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: Day 0 | 98.5 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 1 | 499 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 2 | 299 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 3 | 357 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: Day 0 | 47.1 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 1 | 423 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 2 | 267 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 3 | 247 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 3 | 265 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: Day 0 | 90.2 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: Day 0 | 108 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: Day 0 | 38.0 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 1 | 586 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 2 | 476 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 1 | 503 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 3 | 393 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 2 | 262 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: Day 0 | 188 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 2 | 361 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 1 | 1163 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 1 | 449 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 2 | 703 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 3 | 388 titer (1/dilution) |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 3 | 735 titer (1/dilution) |
Secondary
Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix 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 ELISA and/or dengue reverse transcriptase-polymerase chain reactions.
Time frame: From Day 0 up to 6 months after the last CYD or Cervarix vaccination
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix or CYD Dengue Vaccine | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix or CYD Dengue Vaccine | 0 Participants |
Secondary
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix 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.
Time frame: Within 30 minutes after each and any vaccination
Population: Analysis was performed on safety analysis set which included those participants who had received at least one dose of the study vaccines. Here, number analyzed signifies participants with available data for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine | After any CYD/Cervarix vaccination | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD/Cervarix vaccination 1 | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD/Cervarix vaccination 2 | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD vaccination 3 | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD vaccination 3 | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine | After any CYD/Cervarix vaccination | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD/Cervarix vaccination 2 | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD/Cervarix vaccination 1 | 0 Participants |
Secondary
Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix 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.
Time frame: Up to 7 days after any and each vaccination
Population: Analysis was performed on safety analysis set. Here, 'number analyzed' signifies participants with available data for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post any CYD/Cervarix vaccination | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD/Cervarix vaccination 2 | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD/Cervarix vaccination 1 | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD/Cervarix vaccination 3 | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD/Cervarix vaccination 3 | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post any CYD/Cervarix vaccination | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD/Cervarix vaccination 1 | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD/Cervarix vaccination 2 | 0 Participants |
Secondary
Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine
An SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. An AESIs were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.
Time frame: From Day 0 up to 6 months after the last CYD or Cervarix vaccination
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine | SAE | 6 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine | Serious AESI | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine | SAE | 0 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine | Serious AESI | 0 Participants |
Secondary
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine
Solicited injection site reactions included pain, erythema, and swelling.
Time frame: Up to 7 days after each and any vaccination
Population: Analysis was performed on safety analysis set. Here, number analyzed signifies participants with available data for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Erythema: Post CYD/Cervarix vaccination 1 | 49 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Pain: Post any CYD/Cervarix vaccine | 212 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Pain: Post CYD/Cervarix vaccination 1 | 202 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Pain: Post CYD/Cervarix vaccination 2 | 173 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Pain: Post CYD vaccination 3 | 65 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Erythema: Post any CYD/Cervarix vaccine | 64 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Erythema: Post CYD/Cervarix vaccination 2 | 41 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Erythema: Post CYD vaccination 3 | 6 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Swelling: Post any CYD/Cervarix vaccine | 73 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Swelling: Post CYD/Cervarix vaccination 1 | 55 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Swelling: Post CYD/Cervarix vaccination 2 | 48 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Swelling: Post CYD vaccination 3 | 8 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Swelling: Post CYD/Cervarix vaccination 2 | 35 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Erythema: Post CYD/Cervarix vaccination 2 | 34 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Pain: Post any CYD/Cervarix vaccine | 221 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Swelling: Post CYD/Cervarix vaccination 1 | 44 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Pain: Post CYD/Cervarix vaccination 1 | 206 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Erythema: Post CYD vaccination 3 | 11 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Pain: Post CYD/Cervarix vaccination 2 | 169 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Swelling: Post CYD vaccination 3 | 10 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Pain: Post CYD vaccination 3 | 59 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Swelling: Post any CYD/Cervarix vaccine | 60 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Erythema: Post any CYD/Cervarix vaccine | 61 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Erythema: Post CYD/Cervarix vaccination 1 | 43 Participants |
Secondary
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine
Solicited systemic reactions included Fever, Headache, Malaise, Myalgia, and Asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.
Time frame: Up to 14 days after any and each vaccination
Population: Analysis was performed on safety analysis set. Here, number analyzed signifies participants with available data for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Malaise: Post CYD vaccination 3 (Visit 7) | 19 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Headache: Post any vaccination | 101 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Myalgia: Post any vaccination | 160 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Headache: Post CYD vaccination 3 (Visit 7) | 18 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Myalgia: Post vaccination 1 (Visit 1) | 129 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Fever: Post any vaccination | 25 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Myalgia: Post vaccination 2 (Visit 4) | 96 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Malaise: Post any vaccination | 113 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Headache: Post vaccination 1 (Visit 1) | 83 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Myalgia: Post CYD vaccination 3 (Visit 7) | 26 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Malaise: Post vaccination 1 (Visit 1) | 84 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Asthenia: Post any vaccination | 93 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Fever: Post vaccination 1 (Visit 1) | 14 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Asthenia: Post vaccination 1 (Visit 1) | 72 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Fever: Post CYD vaccination 3 (Visit 7) | 5 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Malaise: Post vaccination 2 (Visit 4) | 73 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Asthenia: Post vaccination 2 (Visit 4) | 51 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Headache: Post vaccination 2 (Visit 4) | 47 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Fever: Post vaccination 2 (Visit 4) | 10 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Asthenia: Post CYD vaccination 3 (Visit 7) | 16 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Myalgia: Post any vaccination | 168 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Myalgia: Post CYD vaccination 1 (Visit 2) | 76 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Myalgia: Post vaccination 2 (Visit 4) | 95 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Myalgia: Post CYD vaccination 2 (Visit 5) | 60 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Myalgia: Post CYD vaccination 3 (Visit 7) | 31 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Asthenia: Post any vaccination | 95 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Asthenia: Post vaccination 1 (Visit 1) | 53 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Asthenia: Post CYD vaccination 1 (Visit 2) | 47 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Asthenia: Post vaccination 2 (Visit 4) | 35 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Asthenia: Post CYD vaccination 2 (Visit 5) | 30 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Malaise: Post CYD vaccination 3 (Visit 7) | 28 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Asthenia: Post CYD vaccination 3 (Visit 7) | 13 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Fever: Post any vaccination | 35 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Fever: Post vaccination 1 (Visit 1) | 8 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Fever: Post CYD vaccination 1 (Visit 2) | 14 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Fever: Post vaccination 2 (Visit 4) | 12 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Fever: Post CYD vaccination 2 (Visit 5) | 8 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Fever: Post CYD vaccination 3 (Visit 7) | 3 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Headache: Post any vaccination | 111 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Headache: Post vaccination 1 (Visit 1) | 69 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Headache: Post CYD vaccination 1 (Visit 2) | 54 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Headache: Post vaccination 2 (Visit 4) | 48 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Headache: Post CYD vaccination 2 (Visit 5) | 36 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Headache: Post CYD vaccination 3 (Visit 7) | 15 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Malaise: Post any vaccination | 133 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Malaise: Post vaccination 1 (Visit 1) | 84 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Malaise: Post CYD vaccination 1 (Visit 2) | 56 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Malaise: Post vaccination 2 (Visit 4) | 72 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Malaise: Post CYD vaccination 2 (Visit 5) | 47 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine | Myalgia: Post vaccination 1 (Visit 1) | 124 Participants |
Secondary
Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.
Time frame: Up to 28 days after any and each vaccination
Population: Analysis was performed on safety analysis set. Here, number analyzed signifies participants with available data for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Post any vaccination | 50 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Post vaccination 1 (Visit 1) | 33 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Post vaccination 2 (Visit 4) | 26 Participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD vaccination 3 (Visit 7) | 5 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD vaccination 1 (Visit 2) | 25 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD vaccination 3 (Visit 7) | 5 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Post vaccination 2 (Visit 4) | 23 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Post any vaccination | 76 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Post CYD vaccination 2 (Visit 5) | 15 Participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine | Post vaccination 1 (Visit 1) | 37 Participants |
Secondary
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants
Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.
Time frame: Day 0 and 28 days after each CYD dengue vaccination
Population: Analysis was performed on FAS population. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 1 Serotype: Day 0 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 1 Serotype: 28 days post-vaccination 1 | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 1 Serotype: 28 days post-vaccination 2 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 1 Serotype: 28 days post-vaccination 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 2 Serotype: Day 0 | 84.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 2 Serotype: 28 days post-vaccination 1 | 98.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 2 Serotype: 28 days post-vaccination 2 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 2 Serotype: 28 days post-vaccination 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 3 Serotype: Day 0 | 74.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 3 Serotype: 28 days post-vaccination 1 | 95.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 3 Serotype: 28 days post-vaccination 2 | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 3 Serotype: 28 days post-vaccination 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | All 4 Serotypes: Day 0 | 59.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | All 4 Serotypes: 28 days post-vaccination 1 | 92.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | All 4 Serotypes: 28 days post-vaccination 2 | 97.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | All 4 Serotypes: 28 days post-vaccination 3 | 98.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | All 4 Serotypes: 28 days post-vaccination 3 | 97.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 1 Serotype: Day 0 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 3 Serotype: Day 0 | 72.8 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 1 Serotype: 28 days post-vaccination 1 | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | All 4 Serotypes: Day 0 | 55.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 1 Serotype: 28 days post-vaccination 2 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 3 Serotype: 28 days post-vaccination 1 | 94.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 1 Serotype: 28 days post-vaccination 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | All 4 Serotypes: 28 days post-vaccination 2 | 97.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 2 Serotype: Day 0 | 82.8 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 3 Serotype: 28 days post-vaccination 2 | 98.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 2 Serotype: 28 days post-vaccination 1 | 98.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | All 4 Serotypes: 28 days post-vaccination 1 | 92.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 2 Serotype: 28 days post-vaccination 2 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 3 Serotype: 28 days post-vaccination 3 | 98.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants | At least 2 Serotype: 28 days post-vaccination 3 | 100.0 percentage of participants |
Secondary
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants
Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.
Time frame: Day 0 and 28 days after each CYD dengue vaccine vaccination
Population: Analysis was performed on FAS population. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 3 | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: Day 0 | 82.5 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 1 | 94.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 1 | 96.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: Day 0 | 92.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 2 | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 2 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 3 | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 1 | 96.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: Day 0 | 68.8 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 2 | 97.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 1 | 97.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 2 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: Day 0 | 74.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 3 | 98.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: Day 0 | 68.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 1 | 95.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 2 | 97.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 1: 28 days post-vaccination 3 | 97.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: Day 0 | 91.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 1 | 93.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 2 | 98.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 2: 28 days post-vaccination 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: Day 0 | 83.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 1 | 96.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 2 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 3: 28 days post-vaccination 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: Day 0 | 66.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 1 | 98.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants | Serotype 4: 28 days post-vaccination 2 | 100.0 percentage of participants |
Secondary
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants
Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (\<10, \>=10 and \>=100 \[1/dil\]) against each dengue virus serotypes of CYD were reported.
Time frame: Day 0 and 28 days after each CYD dengue vaccination
Population: Analysis was performed on FAS population. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Pre-vaccination 1 >=10 (1/dil) | 74.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Pre-vaccination 1 <10 (1/dil) | 17.5 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Pre-vaccination 1 <10 (1/dil) | 7.1 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Pre-vaccination 1 >=10 (1/dil) | 82.5 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 2 <10 (1/dil) | 2.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Pre-vaccination 1 >=100 (1/dil) | 51.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Pre-vaccination 1 >=10 (1/dil) | 92.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 1 <10 (1/dil) | 3.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 1 <10 (1/dil) | 5.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 1 >=10 (1/dil) | 96.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Pre-vaccination 1 >=100 (1/dil) | 59.1 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 1 >=100 (1/dil) | 88.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 2 >=10 (1/dil) | 97.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 2 <10 (1/dil) | 0.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 1 <10 (1/dil) | 3.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 2 >=10 (1/dil) | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Pre-vaccination 1 <10 (1/dil) | 26.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 2 >=100 (1/dil) | 87.2 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 1 >=10 (1/dil) | 96.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 3 <10 (1/dil) | 0.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 2 >=100 (1/dil) | 77.2 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 3 >=10 (1/dil) | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 1 >=100 (1/dil) | 91.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 3 >=100 (1/dil) | 94.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 1 >=10 (1/dil) | 94.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Pre-vaccination 1 <10 (1/dil) | 31.2 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 2 <10 (1/dil) | 0.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Pre-vaccination 1 >=10 (1/dil) | 68.8 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 3 <10 (1/dil) | 0.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 2 >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 1 <10 (1/dil) | 2.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Pre-vaccination 1 >=100 (1/dil) | 61.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 1 >=10 (1/dil) | 97.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 2 >=100 (1/dil) | 90.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 1 >=100 (1/dil) | 87.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 3 >=10 (1/dil) | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 2 <10 (1/dil) | 0.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 3 <10 (1/dil) | 0.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 2 >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 1 >=100 (1/dil) | 82.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 2 >=100 (1/dil) | 82.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 3 >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 3 <10 (1/dil) | 0.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 3 >=100 (1/dil) | 74.8 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 3 >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 3 >=100 (1/dil) | 95.1 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 3 >=100 (1/dil) | 83.2 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Pre-vaccination 1 >=100 (1/dil) | 33.1 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 3 >=100 (1/dil) | 83.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Pre-vaccination 1 <10 (1/dil) | 31.1 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Pre-vaccination 1 >=10 (1/dil) | 68.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Pre-vaccination 1 >=100 (1/dil) | 56.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 1 <10 (1/dil) | 4.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 1 >=10 (1/dil) | 95.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 1 >=100 (1/dil) | 78.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 2 <10 (1/dil) | 2.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 2 >=10 (1/dil) | 97.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 2 >=100 (1/dil) | 72.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 3 <10 (1/dil) | 2.1 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 3 >=10 (1/dil) | 97.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 1: Post-vaccination 3 >=100 (1/dil) | 76.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Pre-vaccination 1 <10 (1/dil) | 8.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Pre-vaccination 1 >=10 (1/dil) | 91.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Pre-vaccination 1 >=100 (1/dil) | 61.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 1 <10 (1/dil) | 6.1 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 1 >=10 (1/dil) | 93.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 1 >=100 (1/dil) | 91.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 2 <10 (1/dil) | 1.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 2 >=10 (1/dil) | 98.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 2 >=100 (1/dil) | 90.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 3 <10 (1/dil) | 0.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 3 >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 2: Post-vaccination 3 >=100 (1/dil) | 90.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Pre-vaccination 1 <10 (1/dil) | 16.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Pre-vaccination 1 >=10 (1/dil) | 83.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Pre-vaccination 1 >=100 (1/dil) | 49.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 1 <10 (1/dil) | 3.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 1 >=10 (1/dil) | 96.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 1 >=100 (1/dil) | 87.8 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 2 <10 (1/dil) | 0.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 2 >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 2 >=100 (1/dil) | 87.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 3 <10 (1/dil) | 0.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 3 >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 3: Post-vaccination 3 >=100 (1/dil) | 90.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Pre-vaccination 1 <10 (1/dil) | 33.1 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Pre-vaccination 1 >=10 (1/dil) | 66.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Pre-vaccination 1 >=100 (1/dil) | 29.8 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 1 <10 (1/dil) | 1.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 1 >=10 (1/dil) | 98.6 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 1 >=100 (1/dil) | 89.9 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 2 <10 (1/dil) | 0.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 2 >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 2 >=100 (1/dil) | 80.1 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 3 <10 (1/dil) | 1.4 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants | Serotype 4: Post-vaccination 3 >=10 (1/dil) | 98.6 percentage of participants |
Secondary
Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants
Neutralizing antibodies against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (greater than \[\>\] lower limit of quantitation \[LLOQ\] of the assay) or \>=4-fold rise in antibody titer if seropositive at baseline (i.e., at least one antibody levels against Cervarix HPV antigens \> LLOQ at baseline). The LLOQ for HPV-16 and HPV-18 was less than (\<) 2.0 International Units per milliliter (IU/mL).
Time frame: 28 days after each Cervarix vaccination
Population: Analysis was performed on FAS population. Here, overall number of participants signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18: 28 days post-vaccination 1 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16: 28 days post-vaccination 1 | 98.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18: 28 days post-vaccination 2 | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Concomitant Administration) | Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16: 28 days post-vaccination 2 | 98.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18: 28 days post-vaccination 2 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16: 28 days post-vaccination 2 | 99.3 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-18: 28 days post-vaccination 1 | 98.7 percentage of participants |
| CYD Dengue Vaccine + Cervarix (Sequential Administration) | Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants | HPV-16: 28 days post-vaccination 1 | 99.3 percentage of participants |