Dengue Fever, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue Fever, Dengue virus, Dengue Hemorrhagic Fever, CYD Dengue Vaccine
Brief summary
The aim of the study was to assess the immune response and the safety of different vaccination schedules of CYD dengue vaccine. The primary objectives of the study were: * To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants 28 days after the last injection. * To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD vaccine given as a 3-dose schedule (Group 1) in previously dengue exposed participants, 1 year after the last injection. * To demonstrate the non-inferiority of the immune response elicited against each dengue serotype elicited by a booster dose of CYD dengue vaccine one year or two years after the last injection in the primary series in previously dengue exposed participants, compared to the immune response post dose 3 in Group 1. The secondary objectives of the study were: * To demonstrate the superiority of the immune response elicited by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants, 28 days after the last injection. * To demonstrate the superiority of the immune response elicited by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants, one year after the last injection. * To describe the neutralizing antibody levels of each dengue serotype at 28 days post-injection 3 to the antibody levels immediately before receiving a booster dose, by baseline dengue serostatus. * To describe the neutralizing antibody levels of each dengue serotype at 28 days post-injection 2 and 28 days post-injection 3 from Group 1 in a primary series schedule by baseline dengue serostatus. * To demonstrate the superiority of the immune response elicited against each dengue serotype 28 days after administration of a booster dose of CYD dengue vaccine, in previously dengue exposed participants, at one year or two years after last injection in the primary series. * To describe the seroconversion rate 28 days post-booster injection in all 3 groups. * To describe all hospitalized virologically confirmed dengue (VCD) cases during the study. * To evaluate the safety profile of CYD after each and any injection during the trial. Safety assessments include 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.
Detailed description
Healthy participants aged between 9 and 50 year received CYD dengue vaccine in various schedules, in two sequential stages. In the first stage, participants received 1, 2 or 3 injections of CYD dengue vaccine over a 12-month period. In the second stage, participants were randomized to receive a booster dose of CYD dengue vaccine at either 12 months (Subgroup a) or 24 months (Subgroup b) after the third injection of study vaccine. During the conduction of this trial, the World Health Organization (WHO) indication about vaccinating only baseline seropositive participants was arisen; at this moment, STAGE I of the trial was completed. For STAGE II, only participants who were previously dengue exposed at baseline (dengue seropositive) were eligible to receive the booster dose.
Interventions
BIOLOGICALCYD Dengue Vaccine
0.5 mL, Subcutaneous
BIOLOGICALPlacebo (Sodium chloride 0.9%)
0.5 mL, Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 9 to 50 years on the day of enrollment. * Participant in good health, based on medical history and physical examination. * Assent form or informed consent form (ICF) had been signed and dated by the participant (based on local regulations), and 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 and parent(s)/legally acceptable representative(s) were able to attend all scheduled visits and to comply with all trial procedures.
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 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. * Self-reported or suspected congenital or acquired immunodeficiency; 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). * Self-reported systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances. * Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion. * Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response. * Planned receipt of any vaccine in the 4 weeks following any trial vaccination. * Previous vaccination against dengue disease with either the trial vaccine or another vaccine. * 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. * Identified as a site employee of the Investigator, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife, and their children, adopted or natural) of the employees or the Investigator. * A prospective participant must not be included in the study until the following conditions and/or symptoms were resolved: * Febrile illness (temperature greater than or equal to \[\>=\] 38.0 degree Celsius) or moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | 28 days after last CYD dengue vaccination | GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3, or 4) were assessed using plaque reduction neutralization test (PRNT) assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline was defined as participants with titers \>=10 (1/dilution) for at least 1 serotype with parental dengue virus strains. Per-protocol analysis set (PPAS) included all participants who had no protocol violations; and who met any of following study violations were excluded from PPAS (STAGE I/II): had not met all protocol-specified inclusion/exclusion criteria, had not received correct doses or injections, received vaccine other than randomized schedule, did not receive vaccination in proper time window, had not provided post-dose serology sample in proper time window, received protocol-restricted medication, therapy, or vaccine. |
| STAGE-I: Geometric Mean Titers Against Each Dengue Virus Serotype 1 Year After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | 1 year after last CYD dengue vaccination | GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. |
| STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Group 1: 28 days post-dose 3 in STAGE-I, Group 1a: 28 days post 12 months booster dose in STAGE-II | GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Data of Group 1 (28 days post-dose 3 in STAGE-I) and Group 1a (28 days 12 months Booster dose) were reported and compared in this outcome measure. GMT paired ratio (given in statistical analysis section) was calculated by dividing geometric mean values of Group 1a: 28 days post 12 months booster dose in STAGE-II by Group 1: 28 days post-dose 3 in STAGE-I. |
| STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Group 1: 28 days post-dose 3 in STAGE-I, Group 2a: 28 days post 12 months booster dose in STAGE-II | GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Data of Group 1 (28 days post-dose 3 in STAGE-I) and Group 2a (28 days post 12 months Booster dose) were reported and compared in this outcome measure. GMT ratio (given in statistical analysis section) was calculated by dividing geometric mean values of Group 2a: 28 days post 12 months booster dose in STAGE-II by Group 1: 28 days Post-dose 3 in STAGE-I. |
| STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Group 1: 28 days post-dose 3 in STAGE-I, Group 1b: 28 days post 24 months booster dose in STAGE-II | GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Data of Group 1 (28 days post-dose 3 in STAGE-I) and Group 1b (28 days post 24 months booster dose) were reported and compared in this outcome measure. GMT paired ratio (given in statistical analysis section) was calculated by dividing geometric mean values of Group 1b: 28 days post 24 months booster dose in STAGE-II by Group 1: 28 days Post-dose 3 in STAGE-I. |
| STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Group 1: 28 days post-dose 3 in STAGE-I, Group 2b: 28 days post 24 months Booster dose in STAGE-II | GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Data of Group 1 (28 days post-dose 3 in STAGE-I) and Group 2b (28 days post 24 months Booster dose) was reported and compared in this outcome measure. GMT ratio (given in statistical analysis section) was calculated by dividing geometric mean values of Group 2b: 28 days post 24 months booster dose in STAGE-II by Group 1: 28 days post-dose 3 in STAGE-I. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| STAGE-I: Number of Participants With Immediate Unsolicited Adverse Events Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Within 30 minutes after any vaccination (1, 2, or 3) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. Immediate unsolicited AE were AEs that occurred within 30 minutes after any vaccination. |
| STAGE-II: Number of Participants With Immediate Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | Within 30 minutes after CYD booster vaccination | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and / or onset post-vaccination. Immediate unsolicited AE were AEs that occurred within 30 minutes after vaccination. |
| STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Within 7 days after any vaccination (1, 2, or 3) | Adverse reaction (AR) was defined as all noxious and unintended responses to a medicinal product related to any dose. A Solicited Reaction (SR) was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reaction was an AR at and around the injection site that included pain, erythema, and swelling. |
| STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Within 7 days after each vaccination (1, 2, and 3) | AR was defined as all noxious and unintended responses to a medicinal product related to any dose. An SR was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reaction was an AR at and around the injection site that included pain, erythema, and swelling. |
| STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Within 14 days after any vaccination (1, 2, or 3) | An AR was defined as all noxious and unintended responses to a medicinal product related to any dose. An SR was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Systemic AEs were all AEs that were not injection site reactions. Solicited systemic reactions included fever, headache, malaise, myalgia, and asthenia. |
| STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Within 14 days after each vaccination (1, 2, and 3) | An AR was defined as all noxious and unintended responses to a medicinal product related to any dose. A SR was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise, myalgia, and asthenia. |
| STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 28 days and 1 year after last CYD dengue vaccination | GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. |
| STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Within 14 days after CYD booster vaccination | An AR was defined as all noxious and unintended responses to a medicinal product related to any dose. A SR was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise, myalgia, and asthenia. |
| STAGE-I: Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With CYD Dengue Vaccine or Placebo | Within 28 days after any vaccination (1, 2, or 3) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. |
| STAGE-II: Number of Participants Reporting Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | Within 28 days after CYD booster Vaccination | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. |
| STAGE-I: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Event of Special Interests (AESI) Following Vaccination With CYD Dengue Vaccine or Placebo | From Day 0 (post vaccination) up to 12 months after last vaccination in STAGE-I (i.e., up to 24 months) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was an important medical event. AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. |
| STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | From Month 25 up to 6 months after CYD booster injection (either at 1 year or 2 year) (i.e., up to 30 months for Groups 1a, 2a, and 3a and up to 42 months for Groups 1b, 2b, and 3b) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was an important medical event. AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. |
| STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Within 7 days after CYD booster vaccination | An AR was defined as all noxious and unintended responses to a medicinal product related to any dose. A SR was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reaction was an AR at and around the injection site that included pain, erythema, and swelling. |
| STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Baseline, 28 days post vaccination 3, and 1 year post vaccination 3 | GMTs of antibodies against each of the 4 dengue virus serotypes (parental strains) were assessed using the PRNT assay method. |
| STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Baseline, 28 days post vaccination 3, and 1 year post vaccination 3 | GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3, or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Dengue seronegative participants at Baseline were defined as the participants with valid titer \<0 (1/dilution) for all serotypes with parental dengue virus strains. |
| STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Baseline, 28 days post vaccination-3, and 28 days post booster dose | GMTs of antibodies against each of the 4 dengue virus serotype (1, 2, 3, or 4) were assessed using the PRNT assay. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Titers were measured in terms of 1/dilution. |
| STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Baseline, 28 days post vaccination 3, and 1 year post vaccination 3 | GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay. |
| STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Baseline, 28 days post vaccination 3, and 1 year post vaccination 3 | GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. |
Countries
Colombia, Philippines
Participant flow
Recruitment details
The study was conducted at 6 active centers in 2 countries. A total of 1050 participants were enrolled from 02 May 2016 to 16 September 2016.
Pre-assignment details
Participants were enrolled and randomized in 1:1:1 ratio to 1 of 3 treatment arms in STAGE-I. After STAGE-I, participants identified as seropositive at Baseline were randomized in ratio 1:1 to 1 of 2 subgroups (a \[1a, 2a, 3a\] or b \[1b, 2b, 3b\]) and received one CYD booster vaccine in STAGE-II at either 12 months (Subgroup a) or 24 months (Subgroup b) post last vaccination in STAGE-I. Here, 'M' in the period titles signifies months.
Participants by arm
| Arm | Count |
|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0 (Vaccination 1), Month 6 (Vaccination 2), and Month 12 (Vaccination 3). | 350 |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) Participants received a dose of placebo at Day 0 (Vaccination 1) along with 2 doses of CYD dengue vaccine 0.5 mL SC at Month 6 (Vaccination 2) and Month 12 (Vaccination 3). | 348 |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) Participants received 2 doses of placebo at Day 0 (Vaccination 1) and Month 6 (Vaccination 2) along with a dose of CYD dengue vaccine 0.5 mL SC at Month 12 (Vaccination 3). | 352 |
| Total | 1,050 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Stage-I(24M:12M Treatment+12M Follow-up) | Adverse event (AE) intensity less than (<) Grade 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage-I(24M:12M Treatment+12M Follow-up) | Lost to Follow-up | 5 | 3 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage-I(24M:12M Treatment+12M Follow-up) | Non-compliance with protocol | 9 | 16 | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage-I(24M:12M Treatment+12M Follow-up) | Serious AE (SAE) | 0 | 4 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage-I(24M:12M Treatment+12M Follow-up) | Voluntary withdrawal not due to AE | 21 | 16 | 25 | 0 | 0 | 0 | 0 | 0 | 0 |
| STAGE-II(18M:12M Treatment+6M Follow-up) | Lost to Follow-up | 0 | 0 | 0 | 1 | 1 | 2 | 3 | 1 | 2 |
| STAGE-II(18M:12M Treatment+6M Follow-up) | Non-compliance with protocol | 0 | 0 | 0 | 83 | 83 | 83 | 81 | 84 | 85 |
| STAGE-II(18M:12M Treatment+6M Follow-up) | Other AE | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| STAGE-II(18M:12M Treatment+6M Follow-up) | SAE | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 2 | 3 |
| STAGE-II(18M:12M Treatment+6M Follow-up) | Voluntary withdrawal not due to AE | 0 | 0 | 0 | 5 | 6 | 10 | 12 | 11 | 9 |
Baseline characteristics
| Characteristic | STAGE-I Group 1: CYD Dengue Vaccine | Total | STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) |
|---|---|---|---|---|
| Age, Continuous | 30.8 years STANDARD_DEVIATION 14.42 | 31.1 years STANDARD_DEVIATION 14.49 | 31.1 years STANDARD_DEVIATION 14.62 | 31.3 years STANDARD_DEVIATION 14.47 |
| Dengue Baseline Status Seronegative participants | 52 Participants | 133 Participants | 41 Participants | 40 Participants |
| Dengue Baseline Status Seropositive participants | 281 Participants | 860 Participants | 291 Participants | 288 Participants |
| Dengue Baseline Status Undetermined | 17 Participants | 57 Participants | 20 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 171 Participants | 512 Participants | 169 Participants | 172 Participants |
| Race (NIH/OMB) Asian | 174 Participants | 523 Participants | 177 Participants | 172 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 14 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 190 Participants | 572 Participants | 185 Participants | 197 Participants |
| Sex: Female, Male Male | 160 Participants | 478 Participants | 167 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 348 | 1 / 348 | 1 / 352 | 0 / 55 | 0 / 53 | 0 / 59 | 0 / 56 | 0 / 62 | 0 / 53 |
| other Total, other adverse events | 203 / 348 | 189 / 348 | 182 / 352 | 10 / 55 | 13 / 53 | 15 / 59 | 20 / 56 | 18 / 62 | 15 / 53 |
| serious Total, serious adverse events | 14 / 348 | 26 / 348 | 18 / 352 | 3 / 55 | 2 / 53 | 0 / 59 | 0 / 56 | 2 / 62 | 1 / 53 |
Outcome results
Primary
STAGE-I: Geometric Mean Titers Against Each Dengue Virus Serotype 1 Year After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline
GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains.
Time frame: 1 year after last CYD dengue vaccination
Population: Analysis was performed on PPAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3, as pre-specified in protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Dengue Virus Serotype 1 Year After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 490 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Dengue Virus Serotype 1 Year After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 821 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Dengue Virus Serotype 1 Year After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 477 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Dengue Virus Serotype 1 Year After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 270 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Dengue Virus Serotype 1 Year After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 238 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Dengue Virus Serotype 1 Year After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 504 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Dengue Virus Serotype 1 Year After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 437 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Dengue Virus Serotype 1 Year After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 737 titers |
Comparison: Group 2/Group 1: Serotype 195% CI: [0.757, 1.4]
Comparison: Group 2/Group 1: Serotype 295% CI: [0.705, 1.14]
Comparison: Group 2/Group 1: Serotype 395% CI: [0.724, 1.16]
Comparison: Group 2/Group 1: Serotype 495% CI: [0.72, 1.09]
Primary
STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline
GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3, or 4) were assessed using plaque reduction neutralization test (PRNT) assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline was defined as participants with titers \>=10 (1/dilution) for at least 1 serotype with parental dengue virus strains. Per-protocol analysis set (PPAS) included all participants who had no protocol violations; and who met any of following study violations were excluded from PPAS (STAGE I/II): had not met all protocol-specified inclusion/exclusion criteria, had not received correct doses or injections, received vaccine other than randomized schedule, did not receive vaccination in proper time window, had not provided post-dose serology sample in proper time window, received protocol-restricted medication, therapy, or vaccine.
Time frame: 28 days after last CYD dengue vaccination
Population: Analysis performed on PPAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3, as pre-specified in protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 822 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 875 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 610 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 531 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 510 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 899 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 599 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 869 titers |
Comparison: Group 2/Group 1: Serotype 195% CI: [0.862, 1.39]
Comparison: Group 2/Group 1: Serotype 295% CI: [0.82, 1.2]
Comparison: Group 2/Group 1: Serotype 395% CI: [0.816, 1.18]
Comparison: Group 2/Group 1: Serotype 495% CI: [0.809, 1.14]
Primary
STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline
GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Data of Group 1 (28 days post-dose 3 in STAGE-I) and Group 2a (28 days post 12 months Booster dose) were reported and compared in this outcome measure. GMT ratio (given in statistical analysis section) was calculated by dividing geometric mean values of Group 2a: 28 days post 12 months booster dose in STAGE-II by Group 1: 28 days Post-dose 3 in STAGE-I.
Time frame: Group 1: 28 days post-dose 3 in STAGE-I, Group 2a: 28 days post 12 months booster dose in STAGE-II
Population: Analysis was performed on PPAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 875 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 1023 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 568 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 540 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 270 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 549 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 676 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 828 titers |
Comparison: Group 2a Booster dose/Group 1 Post-dose 3: Serotype 198.75% CI: [0.342, 1.15]
Comparison: Group 2a Booster/Group 1 Post-dose 3: Serotype 298.75% CI: [0.505, 1.3]
Comparison: Group 2a Booster/Group 1 Post-dose 3: Serotype 398.75% CI: [0.732, 1.94]
Comparison: Group 2a Booster/Group 1 Post-dose 3: Serotype 498.75% CI: [0.331, 0.754]
Primary
STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline
GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Data of Group 1 (28 days post-dose 3 in STAGE-I) and Group 2b (28 days post 24 months Booster dose) was reported and compared in this outcome measure. GMT ratio (given in statistical analysis section) was calculated by dividing geometric mean values of Group 2b: 28 days post 24 months booster dose in STAGE-II by Group 1: 28 days post-dose 3 in STAGE-I.
Time frame: Group 1: 28 days post-dose 3 in STAGE-I, Group 2b: 28 days post 24 months Booster dose in STAGE-II
Population: Analysis was performed on PPAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 875 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 1023 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 568 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 540 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 379 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 778 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 517 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Comparison Between Group 2b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 692 titers |
Comparison: Group 2b Booster/Group 1 Post-dose 3: Serotype 198.75% CI: [0.462, 1.71]
Comparison: Group 2b Booster/Group 1 Post-dose 3: Serotype 298.75% CI: [0.402, 1.14]
Comparison: Group 2b Booster/Group 1 Post-dose 3: Serotype 398.75% CI: [0.573, 1.45]
Comparison: Group 2b Booster/Group 1 Post-dose 3: Serotype 498.75% CI: [0.447, 1.1]
Primary
STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline
GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Data of Group 1 (28 days post-dose 3 in STAGE-I) and Group 1a (28 days 12 months Booster dose) were reported and compared in this outcome measure. GMT paired ratio (given in statistical analysis section) was calculated by dividing geometric mean values of Group 1a: 28 days post 12 months booster dose in STAGE-II by Group 1: 28 days post-dose 3 in STAGE-I.
Time frame: Group 1: 28 days post-dose 3 in STAGE-I, Group 1a: 28 days post 12 months booster dose in STAGE-II
Population: Analysis was performed on PPAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 853 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 1186 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 696 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 592 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 383 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 483 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 722 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1a and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 884 titers |
Comparison: Group 1a Booster/Group 1 Post-dose 3: Serotype 198.75% CI: [0.399, 0.805]
Comparison: Group 1a Booster/Group 1 Post-dose 3: Serotype 298.75% CI: [0.55, 1.01]
Comparison: Group 1a Booster/Group 1 Post-dose 3: Serotype 398.75% CI: [0.686, 1.57]
Comparison: Group 1a Booster/Group 1 Post-dose 3: Serotype 498.75% CI: [0.434, 0.963]
Primary
STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline
GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Data of Group 1 (28 days post-dose 3 in STAGE-I) and Group 1b (28 days post 24 months booster dose) were reported and compared in this outcome measure. GMT paired ratio (given in statistical analysis section) was calculated by dividing geometric mean values of Group 1b: 28 days post 24 months booster dose in STAGE-II by Group 1: 28 days Post-dose 3 in STAGE-I.
Time frame: Group 1: 28 days post-dose 3 in STAGE-I, Group 1b: 28 days post 24 months booster dose in STAGE-II
Population: Analysis was performed on PPAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 1017 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 838 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 486 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 556 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 4 | 364 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 1 | 700 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 3 | 559 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Dengue Virus Serotype Within Group 1b and Group 1 After the Third Dose of CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline | Serotype 2 | 730 titers |
Comparison: Group 1b Booster/Group 1 Post-dose 3: Serotype 198.75% CI: [0.479, 0.989]
Comparison: Group 1b Booster/Group 1 Post-dose 3: Serotype 298.75% CI: [0.673, 1.13]
Comparison: Group 1b Booster/Group 1 Post-dose 3: Serotype 398.75% CI: [0.887, 1.49]
Comparison: Group 1b Booster/Group 1 Post-dose 3: Serotype 498.75% CI: [0.471, 0.911]
Secondary
STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2
GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains.
Time frame: 28 days and 1 year after last CYD dengue vaccination
Population: Analysis was performed on FAS population included participants who had received either at least 1 injection of CYD dengue vaccine or placebo; and had at least 1 blood sample drawn and valid post-injection serology results. Here,'Overall number of participant analyzed'=participants with available data for this outcome measure and 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 28 days after last vaccination: Serotype 1 | 834 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 28 days after last vaccination: Serotype 2 | 879 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 28 days after last vaccination: Serotype 3 | 620 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 28 days after last vaccination: Serotype 4 | 527 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 1 year after last vaccination: Serotype 1 | 498 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 1 year after last vaccination: Serotype 2 | 815 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 1 year after last vaccination: Serotype 3 | 477 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 1 year after last vaccination: Serotype 4 | 263 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 1 year after last vaccination: Serotype 4 | 241 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 28 days after last vaccination: Serotype 1 | 877 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 1 year after last vaccination: Serotype 1 | 512 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 28 days after last vaccination: Serotype 2 | 870 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 1 year after last vaccination: Serotype 3 | 444 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 28 days after last vaccination: Serotype 3 | 602 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 1 year after last vaccination: Serotype 2 | 747 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline-Comparison Between Group 1 and Group 2 | 28 days after last vaccination: Serotype 4 | 507 titers |
Comparison: Group2/Group1: Serotype 1 (28 days after last vaccination)95% CI: [0.833, 1.33]
Comparison: Group2/Group1: Serotype 2 (28 days after last vaccination)95% CI: [0.821, 1.19]
Comparison: Group2/Group1: Serotype 3 (28 days after last vaccination)95% CI: [0.81, 1.17]
Comparison: Group2/Group1: Serotype 4 (28 days after last vaccination)95% CI: [0.814, 1.14]
Comparison: Group2/Group1: Serotype 1 (1 year after last vaccination)95% CI: [0.762, 1.39]
Comparison: Group2/Group1: Serotype 2 (1 year after last vaccination)95% CI: [0.724, 1.16]
Comparison: Group2/Group1: Serotype 3 (1 year after last vaccination)95% CI: [0.742, 1.17]
Comparison: Group2/Group1: Serotype 4 (1 year after last vaccination)95% CI: [0.75, 1.12]
Secondary
STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline
GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3, or 4) were assessed using the PRNT assay method. Titers were measured in terms of 1/dilution. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Dengue seronegative participants at Baseline were defined as the participants with valid titer \<0 (1/dilution) for all serotypes with parental dengue virus strains.
Time frame: Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
Population: Analysis was performed on FAS. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure and 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 3: 1 year post injection 3 | 27.5 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 2: 1 year post vaccination 3 | 815 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 2: 1 year post vaccination 3 | 31.3 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 3: Baseline | 5.00 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 1: 28 days post vaccination 3 | 834 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 3: 28 days post vaccination 3 | 64.2 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 3: Baseline | 310 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 2: 28 days post vaccination 3 | 56.2 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 4: Baseline | 5.00 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 4: 28 days post vaccination 3 | 145 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 3: 28 days post vaccination 3 | 620 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 4: 1 year post vaccination 3 | 57.1 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 1: 1 year post vaccination 3 | 10.4 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 3: 1 year post vaccination 3 | 477 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 1: 1 year post vaccination 3 | 498 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 4: Baseline | 147 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 4: 28 days post vaccination 3 | 527 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 1: Baseline | 239 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 4: 1 year post vaccination 3 | 263 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 2: Baseline | 331 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 1: Baseline | 5.00 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 1: 28 days post vaccination 3 | 32.4 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 2: 28 days post vaccination 3 | 879 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 2: Baseline | 5.00 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 1: 1 year post vaccination 3 | 9.01 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 2: 28 days post vaccination 3 | 63.0 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 2: Baseline | 6.47 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 3: 1 year post vaccination 3 | 444 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 2: 1 year post vaccination 3 | 28.7 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 2: 1 year post vaccination 3 | 747 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 1: Baseline | 5.57 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 3: Baseline | 5.69 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 2: Baseline | 326 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 4: Baseline | 123 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 3: 28 days post vaccination 3 | 53.7 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 1: 1 year post vaccination 3 | 512 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 2: 28 days post vaccination 3 | 870 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 3: 1 year post injection 3 | 25.3 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 3: Baseline | 290 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 4: 28 days post vaccination 3 | 507 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 4: Baseline | 5.41 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 1: 28 days post vaccination 3 | 877 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 1: 28 days post vaccination 3 | 34.3 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 4: 28 days post vaccination 3 | 164 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 1: Baseline | 304 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 4: 1 year post vaccination 3 | 241 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 4: 1 year post vaccination 3 | 53.8 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 3: 28 days post vaccination 3 | 602 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 4: 1 year post vaccination 3 | 40.8 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 2: 28 days post vaccination 3 | 1046 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 1: 28 days post vaccination 3 | 1201 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 1: 1 year post vaccination 3 | 618 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 2: Baseline | 293 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 2: 1 year post vaccination 3 | 798 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 3: Baseline | 269 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 3: 28 days post vaccination 3 | 694 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 3: 1 year post vaccination 3 | 390 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 4: Baseline | 118 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 4: 28 days post vaccination 3 | 581 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 4: 1 year post vaccination 3 | 227 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 1: Baseline | 5.49 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 1: 28 days post vaccination 3 | 20.2 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 1: 1 year post vaccination 3 | 8.04 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 2: Baseline | 5.86 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 2: 28 days post vaccination 3 | 55.2 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 2: 1 year post vaccination 3 | 30.9 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 3: Baseline | 6.09 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 3: 28 days post vaccination 3 | 49.5 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 3: 1 year post injection 3 | 21.8 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 4: Baseline | 5.64 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seronegative- Serotype 4: 28 days post vaccination 3 | 349 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains (by Baseline Dengue Status) in Participants Who Were Seropositive and Seronegative at Baseline | Seropositive- Serotype 1: Baseline | 328 titers |
Secondary
STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants
GMTs of antibodies against each of the 4 dengue virus serotypes (parental strains) were assessed using the PRNT assay method.
Time frame: Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
Population: Analysis was performed on FAS. Here, 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: Baseline | 131 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 28 days post vaccination 3 | 497 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 1 year post vaccination 3 | 259 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: Baseline | 172 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 28 days post vaccination 3 | 567 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 1 year post vaccination 3 | 470 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: Baseline | 163 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 28 days post vaccination 3 | 432 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 1 year post vaccination 3 | 294 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: Baseline | 86.7 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 28 days post vaccination 3 | 429 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 1 year post vaccination 3 | 203 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 1 year post vaccination 3 | 192 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: Baseline | 187 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: Baseline | 180 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 1 year post vaccination 3 | 288 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 28 days post vaccination 3 | 586 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 1 year post vaccination 3 | 457 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 28 days post vaccination 3 | 441 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 1 year post vaccination 3 | 279 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 28 days post vaccination 3 | 446 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 28 days post vaccination 3 | 628 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: Baseline | 202 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: Baseline | 83.8 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: Baseline | 181 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 28 days post vaccination 3 | 734 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: Baseline | 81.2 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 1 year post vaccination 3 | 500 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: Baseline | 169 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 28 days post vaccination 3 | 505 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 28 days post vaccination 3 | 546 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: Baseline | 198 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 28 days post vaccination 3 | 735 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 1 year post vaccination 3 | 258 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 1 year post vaccination 3 | 331 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 1 year post vaccination 3 | 177 titers |
Secondary
STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline
GMTs of antibodies against each of the 4 dengue virus serotype (1, 2, 3, or 4) were assessed using the PRNT assay. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains. Titers were measured in terms of 1/dilution.
Time frame: Baseline, 28 days post vaccination-3, and 28 days post booster dose
Population: Analysis was performed on FAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure and 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3:28 days post booster dose | 721 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination 3 | 733 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 828 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4 : 28 days post booster dose | 380 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1 : 28 days post booster dose | 505 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4:28 day post vaccination 3 | 512 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : Baseline | 370 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 986 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: Baseline | 246 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4: Baseline | 147 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post booster dose | 856 titers |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3 : Baseline | 363 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post booster dose | 858 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3 : Baseline | 399 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : Baseline | 335 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4 : 28 days post booster dose | 265 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4:28 day post vaccination 3 | 536 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination 3 | 659 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 897 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1 : 28 days post booster dose | 552 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 933 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3:28 days post booster dose | 667 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: Baseline | 283 titers |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4: Baseline | 142 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post booster dose | 867 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4 : 28 days post booster dose | 300 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1 : 28 days post booster dose | 861 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3:28 days post booster dose | 743 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : Baseline | 283 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: Baseline | 309 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4: Baseline | 115 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3 : Baseline | 287 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination 3 | 725 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 1018 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 1111 titers |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4:28 day post vaccination 3 | 570 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination 3 | 524 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: Baseline | 231 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 840 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : Baseline | 296 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 783 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post booster dose | 813 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3 : Baseline | 266 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1 : 28 days post booster dose | 707 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3:28 days post booster dose | 586 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4: Baseline | 147 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4:28 day post vaccination 3 | 543 titers |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4 : 28 days post booster dose | 368 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 844 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1 : 28 days post booster dose | 749 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: Baseline | 327 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4 : 28 days post booster dose | 360 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4:28 day post vaccination 3 | 480 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : Baseline | 318 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 824 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3:28 days post booster dose | 477 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3 : Baseline | 210 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4: Baseline | 106 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination 3 | 551 titers |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post booster dose | 655 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination 3 | 663 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 1077 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3:28 days post booster dose | 506 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : Baseline | 303 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4 : 28 days post booster dose | 413 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4: Baseline | 122 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1 : 28 days post booster dose | 1199 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 1301 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 4:28 day post vaccination 3 | 593 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 3 : Baseline | 253 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 1: Baseline | 350 titers |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains After Booster CYD Dengue Vaccination in Participants Seropositive at Baseline | Serotype 2 : 28 days post booster dose | 967 titers |
Secondary
STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was an important medical event. 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: From Month 25 up to 6 months after CYD booster injection (either at 1 year or 2 year) (i.e., up to 30 months for Groups 1a, 2a, and 3a and up to 42 months for Groups 1b, 2b, and 3b)
Population: Analysis was performed on SafAS.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | SAE | 3 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | Serious AESI | 0 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | SAE | 0 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | Serious AESI | 0 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | SAE | 2 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | Serious AESI | 0 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | SAE | 2 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | Serious AESI | 0 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | SAE | 0 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | Serious AESI | 0 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | SAE | 1 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Events Special Interest Following Booster Vaccination With CYD Dengue Vaccine | Serious AESI | 0 Participants |
Secondary
STAGE-II: Number of Participants Reporting Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination.
Time frame: Within 28 days after CYD booster Vaccination
Population: Analysis was performed on SafAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants Reporting Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 1 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants Reporting Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 3 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants Reporting Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 5 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants Reporting Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 3 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants Reporting Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 2 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants Reporting Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 4 Participants |
Secondary
STAGE-II: Number of Participants With Immediate Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and / or onset post-vaccination. Immediate unsolicited AE were AEs that occurred within 30 minutes after vaccination.
Time frame: Within 30 minutes after CYD booster vaccination
Population: Analysis was performed on SafAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants With Immediate Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 0 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants With Immediate Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 0 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants With Immediate Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 0 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants With Immediate Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 0 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Immediate Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 0 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Immediate Unsolicited Adverse Events Following Booster Vaccination With CYD Dengue Vaccine | 0 Participants |
Secondary
STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine
An AR was defined as all noxious and unintended responses to a medicinal product related to any dose. A SR was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reaction was an AR at and around the injection site that included pain, erythema, and swelling.
Time frame: Within 7 days after CYD booster vaccination
Population: Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Erythema | 0 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Pain | 6 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Swelling | 0 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Erythema | 0 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Pain | 7 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Swelling | 0 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Erythema | 0 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Pain | 11 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Swelling | 0 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Erythema | 0 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Pain | 7 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Swelling | 0 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Erythema | 1 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Pain | 12 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Swelling | 1 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Pain | 10 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Swelling | 1 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Injection Site Reactions Following Booster Vaccination With CYD Dengue Vaccine | Erythema | 0 Participants |
Secondary
STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine
An AR was defined as all noxious and unintended responses to a medicinal product related to any dose. A SR was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise, myalgia, and asthenia.
Time frame: Within 14 days after CYD booster vaccination
Population: Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Myalgia | 5 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Headache | 5 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Fever | 1 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Asthenia | 4 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Malaise | 5 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Headache | 11 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Myalgia | 8 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Fever | 0 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Asthenia | 6 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Malaise | 9 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Headache | 6 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Myalgia | 9 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Asthenia | 6 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Malaise | 7 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Fever | 1 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Malaise | 7 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Fever | 2 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Headache | 7 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Myalgia | 9 Participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Asthenia | 7 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Myalgia | 12 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Fever | 2 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Asthenia | 9 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Headache | 11 Participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Malaise | 9 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Fever | 0 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Myalgia | 6 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Headache | 7 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Asthenia | 3 Participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Number of Participants With Solicited Systemic Reactions Following Booster Vaccination With CYD Dengue Vaccine | Malaise | 5 Participants |
Secondary
STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline
GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay method. Dengue seropositive participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strains.
Time frame: Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
Population: Analysis was performed on FAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure and 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1 : 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2: Baseline | 99.3 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination | 100.0 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3 : 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: Baseline | 98.6 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: Baseline | 93.6 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: Baseline | 92.2 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3 : 1 year post vaccination 3 | 99.3 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: Baseline | 96.5 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 1 year post vaccination 3 | 99.3 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination | 100.0 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 99.3 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1 : 1 year post vaccination 3 | 99.3 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: Baseline | 90.3 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2: Baseline | 94.4 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: Baseline | 93.1 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 99.3 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 1 year post vaccination 3 | 99.3 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: Baseline | 89.8 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 1 year post vaccination 3 | 98.6 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: Baseline | 95.2 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3 : 1 year post vaccination 3 | 99.3 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1 : 1 year post vaccination 3 | 99.3 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination | 100.0 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2: Baseline | 94.6 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: Baseline | 91.8 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination | 99.3 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: Baseline | 92.1 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 99.3 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1 : 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2: Baseline | 96.4 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: Baseline | 97.1 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3 : 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: Baseline | 95.0 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 1b: CYD Vaccine + CYD Booster Vaccine (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 99.3 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1 : 1 year post vaccination 3 | 96.9 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: Baseline | 91.7 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 1 year post vaccination 3 | 98.5 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2: Baseline | 94.4 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 99.3 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3 : 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: Baseline | 91.7 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: Baseline | 93.1 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination | 100.0 percentage of participants |
| STAGE-II Group 2b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 1 year post vaccination 3 | 98.5 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: 28 days post vaccination | 100.0 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3 : 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2: Baseline | 97.2 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 1 year post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: Baseline | 94.4 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1 : 1 year post vaccination 3 | 98.5 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 4: 28 days post vaccination 3 | 100.0 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 1: Baseline | 97.2 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 3: Baseline | 100.0 percentage of participants |
| STAGE-II Group 3b: Placebo + CYD + CYD Booster (2 Years) | STAGE-II: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strain in Participants Seropositive at Baseline | Serotype 2 : 1 year post vaccination 3 | 100.0 percentage of participants |
Secondary
STAGE-I: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Event of Special Interests (AESI) Following Vaccination With CYD Dengue Vaccine or Placebo
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was an important medical event. 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: From Day 0 (post vaccination) up to 12 months after last vaccination in STAGE-I (i.e., up to 24 months)
Population: Analysis was performed on SafAS.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Event of Special Interests (AESI) Following Vaccination With CYD Dengue Vaccine or Placebo | SAE | 14 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Event of Special Interests (AESI) Following Vaccination With CYD Dengue Vaccine or Placebo | Serious AESI | 0 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Event of Special Interests (AESI) Following Vaccination With CYD Dengue Vaccine or Placebo | SAE | 26 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Event of Special Interests (AESI) Following Vaccination With CYD Dengue Vaccine or Placebo | Serious AESI | 0 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Event of Special Interests (AESI) Following Vaccination With CYD Dengue Vaccine or Placebo | SAE | 18 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants Reporting Serious Adverse Events Including Serious Adverse Event of Special Interests (AESI) Following Vaccination With CYD Dengue Vaccine or Placebo | Serious AESI | 0 Participants |
Secondary
STAGE-I: Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With CYD Dengue Vaccine or Placebo
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination.
Time frame: Within 28 days after any vaccination (1, 2, or 3)
Population: Analysis was performed on SafAS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With CYD Dengue Vaccine or Placebo | 73 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With CYD Dengue Vaccine or Placebo | 94 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With CYD Dengue Vaccine or Placebo | 75 Participants |
Secondary
STAGE-I: Number of Participants With Immediate Unsolicited Adverse Events Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination)
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. Immediate unsolicited AE were AEs that occurred within 30 minutes after any vaccination.
Time frame: Within 30 minutes after any vaccination (1, 2, or 3)
Population: Analysis was performed on safety analysis set (SafAS) that included participants who had received at least one injection of either CYD dengue vaccine or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Immediate Unsolicited Adverse Events Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | 0 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Immediate Unsolicited Adverse Events Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | 3 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Immediate Unsolicited Adverse Events Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | 0 Participants |
Secondary
STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination)
Adverse reaction (AR) was defined as all noxious and unintended responses to a medicinal product related to any dose. A Solicited Reaction (SR) was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reaction was an AR at and around the injection site that included pain, erythema, and swelling.
Time frame: Within 7 days after any vaccination (1, 2, or 3)
Population: Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Erythema | 4 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Pain | 109 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Swelling | 2 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Erythema | 3 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Pain | 114 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Swelling | 5 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Pain | 97 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Swelling | 5 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Erythema | 3 Participants |
Secondary
STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination)
AR was defined as all noxious and unintended responses to a medicinal product related to any dose. An SR was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reaction was an AR at and around the injection site that included pain, erythema, and swelling.
Time frame: Within 7 days after each vaccination (1, 2, and 3)
Population: Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Pain | 50 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Swelling | 1 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Swelling | 1 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Erythema | 1 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Pain | 61 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Erythema | 0 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post vaccination 1: Swelling | 0 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Erythema | 3 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Pain | 43 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Erythema | 0 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Pain | 61 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Erythema | 3 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post vaccination 1: Swelling | 2 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Pain | 53 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Swelling | 1 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Pain | 49 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Erythema | 0 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Swelling | 2 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post vaccination 1: Swelling | 2 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Pain | 61 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Pain | 35 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Erythema | 2 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Swelling | 2 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Erythema | 1 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Pain | 50 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Erythema | 1 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Injection Site Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Swelling | 2 Participants |
Secondary
STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination)
An AR was defined as all noxious and unintended responses to a medicinal product related to any dose. An SR was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Systemic AEs were all AEs that were not injection site reactions. Solicited systemic reactions included fever, headache, malaise, myalgia, and asthenia.
Time frame: Within 14 days after any vaccination (1, 2, or 3)
Population: Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Asthenia | 98 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Malaise | 114 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Fever | 29 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Headache | 129 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Myalgia | 110 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Headache | 122 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Asthenia | 80 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Myalgia | 92 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Malaise | 98 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Fever | 21 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Asthenia | 71 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Fever | 31 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Malaise | 102 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Myalgia | 86 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Any Vaccination) | Headache | 124 Participants |
Secondary
STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination)
An AR was defined as all noxious and unintended responses to a medicinal product related to any dose. A SR was defined as an AR observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise, myalgia, and asthenia.
Time frame: Within 14 days after each vaccination (1, 2, and 3)
Population: Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Fever | 12 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Malaise | 74 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Fever | 9 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Headache | 54 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Headache | 90 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Asthenia | 40 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Malaise | 50 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Malaise | 46 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Myalgia | 49 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Myalgia | 67 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Asthenia | 29 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Fever | 10 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Asthenia | 63 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Myalgia | 26 Participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Headache | 55 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Headache | 47 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Fever | 8 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Headache | 83 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Malaise | 60 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Myalgia | 55 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Asthenia | 52 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Fever | 7 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Headache | 55 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Malaise | 44 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Myalgia | 33 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Asthenia | 30 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Fever | 8 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Malaise | 41 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Myalgia | 37 Participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Asthenia | 32 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Fever | 12 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Myalgia | 28 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Fever | 9 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Asthenia | 45 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Myalgia | 48 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Headache | 47 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Malaise | 61 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Fever | 13 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Malaise | 39 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Malaise | 47 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 1: Headache | 84 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Myalgia | 35 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Headache | 53 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 3: Asthenia | 21 Participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Number of Participants With Solicited Systemic Reactions Following Vaccination With CYD Dengue Vaccine or Placebo (Post Each Vaccination) | Post-vaccination 2: Asthenia | 33 Participants |
Secondary
STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants
GMTs of antibodies against each of the 4 dengue virus serotypes (1, 2, 3 or 4) were assessed using the PRNT assay.
Time frame: Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
Population: Analysis was performed on FAS. Here, 'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 1 year post vaccination 3 | 95.7 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: Baseline | 77.8 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: Baseline | 79.6 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: Baseline | 82.6 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 28 days post vaccination 3 | 99.7 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 1 year post vaccination 3 | 99.1 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: Baseline | 82.6 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 28 days post vaccination 3 | 96.3 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 28 days post vaccination 3 | 98.2 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 1 year post vaccination 3 | 95.7 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 1 year post vaccination 3 | 88.3 percentage of participants |
| STAGE-I Group 1: CYD Dengue Vaccine | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 28 days post vaccination 3 | 98.5 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: Baseline | 84.1 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 1 year post vaccination 3 | 95.7 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 28 days post vaccination 3 | 98.1 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 28 days post vaccination 3 | 96.6 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: Baseline | 81.4 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 28 days post vaccination 3 | 97.2 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 1 year post vaccination 3 | 87.5 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 28 days post vaccination 3 | 99.4 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: Baseline | 83.8 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 1 year post vaccination 3 | 94.4 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 1 year post vaccination 3 | 96.6 percentage of participants |
| STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: Baseline | 80.5 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 1 year post vaccination 3 | 95.7 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: Baseline | 83.4 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 28 days post vaccination 3 | 94.1 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 1: 1 year post vaccination 3 | 88.3 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: Baseline | 85.2 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 28 days post vaccination 3 | 96.0 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 2: 1 year post vaccination 3 | 94.8 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: Baseline | 87.0 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 28 days post vaccination 3 | 97.5 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 3: 1 year post vaccination 3 | 94.3 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: Baseline | 81.6 percentage of participants |
| STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12) | STAGE-I: Percentage of Participants With Antibodies Titer >=10 (1/Dilution) Against Each Serotype With the Parental Dengue Virus Strains in All Participants | Serotype 4: 28 days post vaccination 3 | 98.8 percentage of participants |