Immunogenicity and Safety of Different Vaccination Schedu... | NCT02628444 | Trialant
NCT02628444
Sponsor
Sanofi Pasteur, a Sanofi Company
Status
Completed
Last Update Posted
Mar 24, 2022Actual
Enrollment
1,050Actual
Phase
Phase 2
Conditions
Dengue Fever
Dengue Hemorrhagic Fever
Interventions
CYD Dengue Vaccine
Placebo (Sodium chloride 0.9%)
Countries
Colombia
Philippines
Protocol Section
Identification Module
NCT ID
NCT02628444
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CYD65
Secondary IDs
ID
Type
Description
Link
U1111-1161-3242
Other Identifier
WHO
2020-002854-25
EudraCT Number
Brief Title
Immunogenicity and Safety of Different Vaccination Schedules of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Years of Age
Official Title
Immunogenicity and Safety of Tetravalent Dengue Vaccine Given in 1-, 2-, or 3- Dose Schedules (STAGE I) Followed by a Single Booster Injection of the Same Vaccine (STAGE II) 1 or 2 Years After the Last Primary Dose in Healthy Subjects 9 to 50 Years of Age in Colombia and the Philippines
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Mar 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2, 2016Actual
Primary Completion Date
Apr 29, 2020Actual
Completion Date
Apr 29, 2020Actual
First Submitted Date
Dec 9, 2015
First Submission Date that Met QC Criteria
Dec 9, 2015
First Posted Date
Dec 11, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 11, 2020
Results First Submitted that Met QC Criteria
Feb 3, 2021
Results First Posted Date
Feb 23, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 15, 2022
Last Update Posted Date
Mar 24, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sanofi Pasteur, a Sanofi CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Dengue Fever
Dengue Hemorrhagic Fever
Keywords
Dengue Fever
Dengue virus
Dengue Hemorrhagic Fever
CYD Dengue Vaccine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,050Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
STAGE-I Group 1: CYD Dengue Vaccine
Experimental
Participants received 3 doses of CYD dengue vaccine 0.5 milliliters (mL) subcutaneously (SC) at Day 0 (Vaccination 1), Month 6 (Vaccination 2), and Month 12 (Vaccination 3).
Biological: CYD Dengue Vaccine
STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12)
Experimental
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).
Biological: CYD Dengue Vaccine
Biological: Placebo (Sodium chloride 0.9%)
STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)
Experimental
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).
Participants from Group 1 who received vaccination in STAGE-I; and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
28 days after last CYD dengue vaccination
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.
1 year after last CYD dengue vaccination
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.
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
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.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
STAGE-I Group 1: CYD Dengue Vaccine
Participants received 3 doses of CYD dengue vaccine 0.5 milliliters (mL) subcutaneously (SC) at Day 0 (Vaccination 1), Month 6 (Vaccination 2), and Month 12 (Vaccination 3).
FG001
STAGE-I Group 2: Placebo + CYD Dengue Vaccine (Months 6,12)
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Biological: CYD Dengue Vaccine
Biological: Placebo (Sodium chloride 0.9%)
STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)
Group 1: 28 days post-dose 3 in STAGE-I, Group 1a: 28 days post 12 months booster dose in STAGE-II
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.
Group 1: 28 days post-dose 3 in STAGE-I, Group 2a: 28 days post 12 months booster dose in STAGE-II
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.
Group 1: 28 days post-dose 3 in STAGE-I, Group 1b: 28 days post 24 months booster dose in STAGE-II
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.
Group 1: 28 days post-dose 3 in STAGE-I, Group 2b: 28 days post 24 months Booster dose in STAGE-II
28 days and 1 year after last CYD dengue vaccination
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.
Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
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.
Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
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.
Baseline, 28 days post vaccination-3, and 28 days post booster dose
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.
Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
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.
Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
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.
Within 30 minutes after any vaccination (1, 2, or 3)
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.
Within 30 minutes after CYD booster vaccination
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.
Within 7 days after any vaccination (1, 2, or 3)
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.
Within 7 days after each vaccination (1, 2, and 3)
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.
Within 14 days after any vaccination (1, 2, or 3)
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.
Within 14 days after each vaccination (1, 2, and 3)
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.
Within 7 days after CYD booster vaccination
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.
Within 14 days after CYD booster vaccination
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.
Within 28 days after any vaccination (1, 2, or 3)
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.
Within 28 days after CYD booster 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
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.
From Day 0 (post vaccination) up to 12 months after last vaccination in STAGE-I (i.e., up to 24 months)
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.
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)
Cali
Colombia
Investigational Site 103
MedellÃn
Colombia
Investigational Primary Site Muntinlupa 201_Satellite Site San Pablo 202
City of Muntinlupa
Philippines
Investigational Site 203
Manila
Philippines
Investigational Site 204
Manila
Philippines
Derived
Coronel-MartInez DL, Park J, Lopez-Medina E, Capeding MR, Cadena Bonfanti AA, Montalban MC, Ramirez I, Gonzales MLA, DiazGranados CA, Zambrano B, Dayan G, Savarino S, Chen Z, Wang H, Sun S, Bonaparte M, Rojas A, Ramirez JC, Verdan MA, Noriega F. Immunogenicity and safety of simplified vaccination schedules for the CYD-TDV dengue vaccine in healthy individuals aged 9-50 years (CYD65): a randomised, controlled, phase 2, non-inferiority study. Lancet Infect Dis. 2021 Apr;21(4):517-528. doi: 10.1016/S1473-3099(20)30767-2. Epub 2020 Nov 16.
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).
FG002
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).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at Baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
FG000350 subjects
FG001348 subjects
FG002352 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Vaccinated
FG000348 subjects
FG001348 subjects
FG002352 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Full Analysis Set (FAS)
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-vaccination serology results.
FG000333 subjects
FG001328 subjects
FG002332 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG000314 subjects
FG001309 subjects
FG002310 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG00036 subjects
FG00139 subjects
FG00242 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Type
Comment
Reasons
Adverse event (AE) intensity less than (<) Grade 1
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Serious AE (SAE)
FG0000 subjects
FG0014 subjects
FG0023 subjects
FG0030 subjects
FG004
Voluntary withdrawal not due to AE
FG00021 subjects
FG00116 subjects
FG00225 subjects
FG0030 subjects
FG004
Non-compliance with protocol
FG0009 subjects
FG00116 subjects
FG0029 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0005 subjects
FG0013 subjects
FG0025 subjects
FG0030 subjects
FG004
STAGE-II(18M:12M Treatment+6M Follow-up)
Type
Comment
Milestone Data
STARTED
Started indicates the number of participants who were enrolled and randomized dengue seropositive subjects at baseline.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003145 subjects
FG004152 subjects
FG005157 subjects
FG006149 subjects
FG007152 subjects
FG008151 subjects
Vaccinated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00355 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00355 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00390 subjects
FG004
Type
Comment
Reasons
Other AE
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Analysis was performed on all randomized population.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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).
BG001
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).
BG002
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).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000350
BG001348
BG002352
BG0031050
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00030.8± 14.42
BG00131.3± 14.47
BG00231.1± 14.62
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000190
BG001197
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG000171
BG001172
BG002
Dengue Baseline Status
Baseline dengue seropositive participants: participants with greater than equal to (>=) 10 (1/dilution) for at least 1 serotype with parental dengue virus strain. Baseline dengue seronegative participants were defined as participants with valid titer less than (<) 10 (1/dilution) for all serotypes with parental dengue virus strains. Baseline dengue status was evaluated in FAS population that included participants who had received either at least 1 injection of either CYD dengue vaccine or placebo and had at least 1 blood sample drawn and valid post-injection serology results.
Count of Participants
Participants
Title
Denominators
Categories
Seropositive participants
Title
Measurements
BG000281
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
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.
Posted
Geometric Mean
95% Confidence Interval
titers
28 days after last CYD dengue vaccination
ID
Title
Description
OG000
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).
OG001
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).
Units
Counts
Participants
OG000265
OG001272
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG000822(700 to 964)
OG001899(752 to 1075)
Serotype 2
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Group 2/Group 1: Serotype 1
GMT Ratio
1.09
2-Sided
95
0.862
1.39
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (Group 2/Group 1) was greater than (>) 1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
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.
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.
Posted
Geometric Mean
95% Confidence Interval
titers
1 year after last CYD dengue vaccination
ID
Title
Description
OG000
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).
OG001
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).
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.
Analysis was performed on PPAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure.
Posted
Geometric Mean
98.75% Confidence Interval
titers
Group 1: 28 days post-dose 3 in STAGE-I, Group 1a: 28 days post 12 months booster dose in STAGE-II
ID
Title
Description
OG000
Group 1: CYD Dengue Vaccine-28 Days Post-dose 3 in STAGE-I
Participants who received 3 doses of CYD dengue vaccine in STAGE-I, and were seropositive at Baseline were assessed 28 days after third CYD vaccine in STAGE-I.
OG001
Group 1a: CYD Dengue Vaccine-28 Days Post 12 Month Booster Dose
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.
Analysis was performed on PPAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure.
Posted
Geometric Mean
98.75% Confidence Interval
titers
Group 1: 28 days post-dose 3 in STAGE-I, Group 2a: 28 days post 12 months booster dose in STAGE-II
ID
Title
Description
OG000
Group 1: CYD Dengue Vaccine-28 Days Post-dose 3 in STAGE-I
Participants who received 3 doses of CYD dengue vaccine in STAGE-I, and were seropositive at Baseline were assessed 28 days after third CYD vaccine in STAGE-I.
OG001
Group 2a: CYD Dengue Vaccine-28 Days Post 12 Months Booster Dose
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.
Analysis was performed on PPAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure.
Posted
Geometric Mean
98.75% Confidence Interval
titers
Group 1: 28 days post-dose 3 in STAGE-I, Group 1b: 28 days post 24 months booster dose in STAGE-II
ID
Title
Description
OG000
Group 1: CYD Dengue Vaccine-28 Days Post-dose 3 in STAGE-I
Participants who received 3 doses of CYD dengue vaccine in STAGE-I, and were seropositive at Baseline were assessed 28 days after third CYD vaccine in STAGE-I.
OG001
Group 1b: CYD Dengue Vaccine-28 Days Post 24 Month Booster Dose
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.
Analysis was performed on PPAS. Here, 'Overall number of participant analyzed'=participants with available data for this outcome measure.
Posted
Geometric Mean
98.75% Confidence Interval
titers
Group 1: 28 days post-dose 3 in STAGE-I, Group 2b: 28 days post 24 months Booster dose in STAGE-II
ID
Title
Description
OG000
Group 1: CYD Dengue Vaccine-28 Days Post-dose 3 in STAGE-I
Participants who received 3 doses of CYD dengue vaccine in STAGE-I, and were seropositive at Baseline were assessed 28 days after third CYD vaccine in STAGE-I.
OG001
Group 2b: CYD Dengue Vaccine-28 Days Post 24 Month Booster Dose
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.
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.
Posted
Geometric Mean
95% Confidence Interval
titers
28 days and 1 year after last CYD dengue vaccination
ID
Title
Description
OG000
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).
OG001
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).
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.
Analysis was performed on FAS. Here, 'Number analyzed'=participants with available data for each specified category.
Posted
Geometric Mean
95% Confidence Interval
titers
Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
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.
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.
Posted
Geometric Mean
95% Confidence Interval
titers
Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
ID
Title
Description
OG000
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).
OG001
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).
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.
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.
Posted
Geometric Mean
95% Confidence Interval
titers
Baseline, 28 days post vaccination-3, and 28 days post booster dose
Participants from Group 1 who received vaccination in STAGE-I; and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
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.
Analysis was performed on FAS. Here, 'Number analyzed'=participants with available data for each specified category.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline, 28 days post vaccination 3, and 1 year post vaccination 3
Participants from Group 1 who received vaccination in STAGE-I; and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
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.
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.
Posted
Count of Participants
Participants
Within 30 minutes after any vaccination (1, 2, or 3)
ID
Title
Description
OG000
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).
OG001
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).
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.
Participants from Group 1 who received vaccination in STAGE-I; and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
OG002
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.
Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
Posted
Count of Participants
Participants
Within 7 days after any vaccination (1, 2, or 3)
ID
Title
Description
OG000
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).
OG001
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).
OG002
STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)
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.
Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
Posted
Count of Participants
Participants
Within 7 days after each vaccination (1, 2, and 3)
ID
Title
Description
OG000
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).
OG001
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).
OG002
STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)
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.
Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
Posted
Count of Participants
Participants
Within 14 days after any vaccination (1, 2, or 3)
ID
Title
Description
OG000
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).
OG001
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).
OG002
STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)
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.
Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
Posted
Count of Participants
Participants
Within 14 days after each vaccination (1, 2, and 3)
ID
Title
Description
OG000
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).
OG001
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).
OG002
STAGE-I Group 3: Placebo + CYD Dengue Vaccine (Month 12)
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.
Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
Participants from Group 1 who received vaccination in STAGE-I; and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
OG002
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.
Analysis was performed on SafAS. Here, 'Number analyzed'=participants with available data for each specified category.
Participants from Group 1 who received vaccination in STAGE-I; and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
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.
Analysis was performed on SafAS.
Posted
Count of Participants
Participants
Within 28 days after any vaccination (1, 2, or 3)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
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.
Participants from Group 1 who received vaccination in STAGE-I; and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
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.
Analysis was performed on SafAS.
Posted
Count of Participants
Participants
From Day 0 (post vaccination) up to 12 months after last vaccination in STAGE-I (i.e., up to 24 months)
ID
Title
Description
OG000
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).
OG001
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).
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.
Analysis was performed on SafAS.
Posted
Count of Participants
Participants
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)
Participants from Group 1 who received vaccination in STAGE-I; and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Unsolicited non-serious AEs: Day 0 to Day 28 post any vaccination SR: within 7 & 14 days post any vaccination; SAE: up to 24 months for STAGE-I); up to 6 months after last vaccination for Stage-2 (i.e., up to 30 months [for Groups 1a, 2a, and 3a]; & up to 42 months [for Groups 1b, 2b, and 3b])
Description
Analysis was performed on SafAS. SR was AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. Reported AEs were presented as pre-specified in the study protocol.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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).
0
348
14
348
203
348
EG001
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).
1
348
26
348
189
348
EG002
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).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at Baseline received a booster dose of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e. at Month 24).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e. at Month 36).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e. at Month 24).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e. at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e. at Month 24).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e. at Month 36).
0
53
1
53
15
53
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial Infarction
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG0030 events0 affected55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
Branchial Cyst
Congenital, familial and genetic disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Thyroid Cyst
Endocrine disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Food Allergy
Immune system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Appendicitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0014 events4 affected348 at risk
EG0023 events3 affected352 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Diarrhoea Infectious
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Groin Abscess
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Hepatitis A
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Orchitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Pneumonia Staphylococcal
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Viral Infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Animal Bite
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Forearm Fracture
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Gun Shot Wound
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Jaw Fracture
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Pathological Fracture
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Rheumatoid Arthritis
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Papillary Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Headache
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Migraine
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Seizure
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Subarachnoid Haemorrhage
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Abortion Spontaneous Incomplete
Pregnancy, puerperium and perinatal conditions
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Threatened Labour
Pregnancy, puerperium and perinatal conditions
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Calculus Urinary
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0010 events0 affected348 at risk
EG0021 events1 affected352 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Bartholin's Cyst
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Dysfunctional Uterine Bleeding
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Uterine Polyp
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Acute Respiratory Distress Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Toxic Skin Eruption
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected348 at risk
EG0010 events0 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected348 at risk
EG0011 events1 affected348 at risk
EG0020 events0 affected352 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Asthenia
General disorders
MedDRA version 18.0
Systematic Assessment
EG000133 events98 affected348 at risk
EG001114 events80 affected348 at risk
EG002100 events71 affected352 at risk
EG0034 events4 affected55 at risk
EG0047 events7 affected53 at risk
EG0056 events6 affected59 at risk
EG0069 events9 affected56 at risk
EG0076 events6 affected62 at risk
EG0083 events3 affected53 at risk
Fever
General disorders
MedDRA version 18.0
Systematic Assessment
EG00031 events29 affected348 at risk
EG00123 events21 affected348 at risk
EG00234 events31 affected352 at risk
EG003
Injection Site Pain
General disorders
MedDRA version 18.0
Systematic Assessment
EG000154 events109 affected348 at risk
EG001164 events114 affected348 at risk
EG002146 events97 affected352 at risk
EG003
Malaise
General disorders
MedDRA version 18.0
Systematic Assessment
Events of malaise that occurred after 14 days post-vaccination were considered as unsolicited AE.
EG000170 events114 affected348 at risk
EG001146 events98 affected348 at risk
EG002148 events103 affected352 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
Events of myalgia that occurred after 14 days post-vaccination were considered as unsolicited AE.
EG000143 events110 affected348 at risk
EG001126 events92 affected348 at risk
EG002112 events87 affected352 at risk
EG003
Headache
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
Events of headache that occurred after 14 days post-vaccination were considered as unsolicited AE.
EG000201 events129 affected348 at risk
EG001190 events123 affected348 at risk
EG002184 events124 affected352 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2/Group 1: Serotype 3
GMT Ratio
0.983
2-Sided
95
0.816
1.18
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2/Group 1: Serotype 4
GMT ratio
0.960
2-Sided
95
0.809
1.14
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
Units
Counts
Participants
OG000185
OG001190
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG000490(398 to 604)
OG001504(403 to 630)
Serotype 2
Title
Measurements
OG000821(704 to 957)
OG001737(611 to 888)
Serotype 3
Title
Measurements
OG000477(405 to 561)
OG001437(368 to 519)
Serotype 4
Title
Measurements
OG000270(235 to 310)
OG001238(205 to 277)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Group 2/Group 1: Serotype 1
GMT Ratio
1.03
2-Sided
95
0.757
1.40
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2/Group 1: Serotype 2
GMT Ratio
0.897
2-Sided
95
0.705
1.14
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2/Group 1: Serotype 3
GMT Ratio
0.917
2-Sided
95
0.724
1.16
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2/Group 1: Serotype 4
GMT Ratio
0.884
2-Sided
95
0.720
1.09
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
Participants from Group 1 (STAGE-I) who were seropositive at Baseline and received a booster dose at 1 year (or 12 months) post last dose in STAGE-I, were assessed 28 days after CYD dengue booster dose vaccination.
Units
Counts
Participants
OG00053
OG00153
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG000853(526 to 1384)
OG001483(281 to 832)
Serotype 2
Title
Measurements
OG0001186(809 to 1738)
OG001884(602 to 1300)
Serotype 3
Title
Measurements
OG000696(483 to 1002)
OG001722(458 to 1140)
Serotype 4
Title
Measurements
OG000592(400 to 876)
OG001383(269 to 545)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Group 1a Booster/Group 1 Post-dose 3: Serotype 1
GMT paired ratio
0.567
2-Sided
98.75
0.399
0.805
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 1a Booster/Group 1 Post-dose 3: Serotype 2
GMT paired ratio
0.746
2-Sided
98.75
0.550
1.01
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 1a Booster/Group 1 Post-dose 3: Serotype 3
GMT paired ratio
1.04
2-Sided
98.75
0.686
1.57
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 1a Booster/Group 1 Post-dose 3: Serotype 4
GMT paired ratio
0.647
2-Sided
98.75
0.434
0.963
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
Participants from Group 2 (STAGE-I) who were seropositive at Baseline and received a booster dose at 1 year (or 12 months) post last dose in STAGE-I, were assessed 28 days after CYD dengue booster dose vaccination.
Units
Counts
Participants
OG000112
OG00158
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG000875(614 to 1248)
OG001549(331 to 911)
Serotype 2
Title
Measurements
OG0001023(771 to 1356)
OG001828(569 to 1203)
Serotype 3
Title
Measurements
OG000568(433 to 745)
OG001676(436 to 1049)
Serotype 4
Title
Measurements
OG000540(418 to 697)
OG001270(200 to 364)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Group 2a Booster dose/Group 1 Post-dose 3: Serotype 1
GMT Ratio
0.627
2-Sided
98.75
0.342
1.15
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2a Booster/Group 1 Post-dose 3: Serotype 2
GMT Ratio
0.809
2-Sided
98.75
0.505
1.30
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2a Booster/Group 1 Post-dose 3: Serotype 3
GMT Ratio
1.19
2-Sided
98.75
0.732
1.94
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2a Booster/Group 1 Post-dose 3: Serotype 4
GMT Ratio
0.499
2-Sided
98.75
0.331
0.754
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
Participants from Group 1 (STAGE-I) who were seropositive at Baseline and received a booster dose at 2 years (or 24 months) post last dose in STAGE-I, were assessed 28 days after CYD dengue booster dose vaccination.
Units
Counts
Participants
OG00048
OG00148
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG0001017(592 to 1746)
OG001700(401 to 1220)
Serotype 2
Title
Measurements
OG000838(554 to 1269)
OG001730(497 to 1071)
Serotype 3
Title
Measurements
OG000486(333 to 708)
OG001559(395 to 792)
Serotype 4
Title
Measurements
OG000556(400 to 774)
OG001364(260 to 510)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Group 1b Booster/Group 1 Post-dose 3: Serotype 1
GMT paired ratio
0.688
2-Sided
98.75
0.479
0.989
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 1b Booster/Group 1 Post-dose 3: Serotype 2
GMT paired ratio
0.871
2-Sided
98.75
0.673
1.13
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 1b Booster/Group 1 Post-dose 3: Serotype 3
GMT paired ratio
1.15
2-Sided
98.75
0.887
1.49
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 1b Booster/Group 1 Post-dose 3: Serotype 4
GMT paired ratio
0.655
2-Sided
98.75
0.471
0.911
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
Participants from Group 1 (STAGE-I) who were seropositive at Baseline and received a booster dose at 2 years (or 24 months) post last dose in STAGE-I, were assessed 28 days after CYD dengue booster dose vaccination.
Units
Counts
Participants
OG000112
OG00150
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG000875(614 to 1248)
OG001778(429 to 1414)
Serotype 2
Title
Measurements
OG0001023(771 to 1356)
OG001692(430 to 1116)
Serotype 3
Title
Measurements
OG000568(433 to 745)
OG001517(365 to 733)
Serotype 4
Title
Measurements
OG000540(418 to 697)
OG001379(261 to 551)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Group 2b Booster/Group 1 Post-dose 3: Serotype 1
GMT ratio
0.889
2-Sided
98.75
0.462
1.71
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2b Booster/Group 1 Post-dose 3: Serotype 2
GMT ratio
0.677
2-Sided
98.75
0.402
1.14
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2b Booster/Group 1 Post-dose 3: Serotype 3
GMT ratio
0.911
2-Sided
98.75
0.573
1.45
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
OG000
OG001
Group 2b Booster/Group 1 Post-dose 3: Serotype 4
GMT ratio
0.702
2-Sided
98.75
0.447
1.10
Non-Inferiority
The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was >1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.
Units
Counts
Participants
OG000281
OG001288
Title
Denominators
Categories
28 days after last vaccination: Serotype 1
ParticipantsOG000274
ParticipantsOG001282
Title
Measurements
OG000834(713 to 975)
OG001877(737 to 1043)
28 days after last vaccination: Serotype 2
ParticipantsOG000274
ParticipantsOG001282
Title
Measurements
OG000879(775 to 997)
OG001
28 days after last vaccination: Serotype 3
ParticipantsOG000274
ParticipantsOG001282
Title
Measurements
OG000620(545 to 704)
OG001
28 days after last vaccination: Serotype 4
ParticipantsOG000274
ParticipantsOG001282
Title
Measurements
OG000527(467 to 595)
OG001
1 year after last vaccination: Serotype 1
ParticipantsOG000192
ParticipantsOG001197
Title
Measurements
OG000498(406 to 611)
OG001
1 year after last vaccination: Serotype 2
ParticipantsOG000192
ParticipantsOG001197
Title
Measurements
OG000815(702 to 947)
OG001
1 year after last vaccination: Serotype 3
ParticipantsOG000192
ParticipantsOG001197
Title
Measurements
OG000477(407 to 558)
OG001
1 year after last vaccination: Serotype 4
ParticipantsOG000192
ParticipantsOG001197
Title
Measurements
OG000263(230 to 302)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Group2/Group1: Serotype 1 (28 days after last vaccination)
GMT Ratio
1.05
2-Sided
95
0.833
1.33
Superiority
The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.
OG000
OG001
Group2/Group1: Serotype 2 (28 days after last vaccination)
GMT Ratio
0.99
2-Sided
95
0.821
1.19
Superiority
The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.
OG000
OG001
Group2/Group1: Serotype 3 (28 days after last vaccination)
GMT Ratio
0.972
2-Sided
95
0.810
1.17
Superiority
The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.
OG000
OG001
Group2/Group1: Serotype 4 (28 days after last vaccination)
GMT Ratio
0.963
2-Sided
95
0.814
1.14
Superiority
The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.
OG000
OG001
Group2/Group1: Serotype 1 (1 year after last vaccination)
GMT Ratio
1.03
2-Sided
95
0.762
1.39
Superiority
The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.
OG000
OG001
Group2/Group1: Serotype 2 (1 year after last vaccination)
GMT Ratio
0.917
2-Sided
95
0.724
1.16
Superiority
The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.
OG000
OG001
Group2/Group1: Serotype 3 (1 year after last vaccination)
GMT Ratio
0.933
2-Sided
95
0.742
1.17
Superiority
The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.
OG000
OG001
Group2/Group1: Serotype 4 (1 year after last vaccination)
GMT Ratio
0.916
2-Sided
95
0.750
1.12
Superiority
The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.
Units
Counts
Participants
OG000333
OG001328
OG002332
Title
Denominators
Categories
Serotype 1: Baseline
ParticipantsOG000333
ParticipantsOG001328
ParticipantsOG002332
Title
Measurements
OG000131(103 to 165)
OG001187(147 to 237)
OG002198(157 to 250)
Serotype 1: 28 days post vaccination 3
ParticipantsOG000326
ParticipantsOG001322
ParticipantsOG002324
Title
Measurements
OG000
Serotype 1: 1 year post vaccination 3
ParticipantsOG000231
ParticipantsOG001232
ParticipantsOG002230
Title
Measurements
OG000
Serotype 2: Baseline
ParticipantsOG000333
ParticipantsOG001328
ParticipantsOG002332
Title
Measurements
OG000
Serotype 2: 28 days post vaccination 3
ParticipantsOG000326
ParticipantsOG001322
ParticipantsOG002324
Title
Measurements
OG000
Serotype 2: 1 year post vaccination 3
ParticipantsOG000231
ParticipantsOG001232
ParticipantsOG002230
Title
Measurements
OG000
Serotype 3: Baseline
ParticipantsOG000333
ParticipantsOG001328
ParticipantsOG002332
Title
Measurements
OG000
Serotype 3: 28 days post vaccination 3
ParticipantsOG000326
ParticipantsOG001322
ParticipantsOG002324
Title
Measurements
OG000
Serotype 3: 1 year post vaccination 3
ParticipantsOG000231
ParticipantsOG001232
ParticipantsOG002230
Title
Measurements
OG000
Serotype 4: Baseline
ParticipantsOG000333
ParticipantsOG001328
ParticipantsOG002332
Title
Measurements
OG000
Serotype 4: 28 days post vaccination 3
ParticipantsOG000326
ParticipantsOG001322
ParticipantsOG002324
Title
Measurements
OG000
Serotype 4: 1 year post vaccination 3
ParticipantsOG000231
ParticipantsOG001232
ParticipantsOG002230
Title
Measurements
OG000
OG002
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).
Units
Counts
Participants
OG000281
OG001288
OG002291
Title
Denominators
Categories
Seropositive- Serotype 1: Baseline
ParticipantsOG000281
ParticipantsOG001288
ParticipantsOG002291
Title
Measurements
OG000239(194 to 295)
OG001304(244 to 379)
OG002328(267 to 404)
Seropositive- Serotype 1: 28 days post vaccination 3
ParticipantsOG000274
ParticipantsOG001282
ParticipantsOG002285
Title
Measurements
OG000
Seropositive- Serotype 1: 1 year post vaccination 3
ParticipantsOG000192
ParticipantsOG001197
ParticipantsOG002197
Title
Measurements
OG000
Seropositive- Serotype 2: Baseline
ParticipantsOG000281
ParticipantsOG001288
ParticipantsOG002291
Title
Measurements
OG000
Seropositive- Serotype 2: 28 days post vaccination 3
ParticipantsOG000274
ParticipantsOG001282
ParticipantsOG002285
Title
Measurements
OG000
Seropositive- Serotype 2: 1 year post vaccination 3
ParticipantsOG000192
ParticipantsOG001197
ParticipantsOG002197
Title
Measurements
OG000
Seropositive- Serotype 3: Baseline
ParticipantsOG000281
ParticipantsOG001288
ParticipantsOG002291
Title
Measurements
OG000
Seropositive- Serotype 3: 28 days post vaccination 3
ParticipantsOG000274
ParticipantsOG001282
ParticipantsOG002285
Title
Measurements
OG000
Seropositive- Serotype 3: 1 year post vaccination 3
ParticipantsOG000192
ParticipantsOG001197
ParticipantsOG002197
Title
Measurements
OG000
Seropositive- Serotype 4: Baseline
ParticipantsOG000281
ParticipantsOG001288
ParticipantsOG002291
Title
Measurements
OG000
Seropositive- Serotype 4: 28 days post vaccination 3
ParticipantsOG000274
ParticipantsOG001282
ParticipantsOG002285
Title
Measurements
OG000
Seropositive- Serotype 4: 1 year post vaccination 3
ParticipantsOG000192
ParticipantsOG001197
ParticipantsOG002197
Title
Measurements
OG000
Seronegative- Serotype 1: Baseline
ParticipantsOG00052
ParticipantsOG00140
ParticipantsOG00241
Title
Measurements
OG000
Seronegative- Serotype 1: 28 days post vaccination 3
ParticipantsOG00052
ParticipantsOG00140
ParticipantsOG00239
Title
Measurements
OG000
Seronegative- Serotype 1: 1 year post vaccination 3
ParticipantsOG00039
ParticipantsOG00135
ParticipantsOG00233
Title
Measurements
OG000
Seronegative- Serotype 2: Baseline
ParticipantsOG00052
ParticipantsOG00140
ParticipantsOG00241
Title
Measurements
OG000
Seronegative- Serotype 2: 28 days post vaccination 3
ParticipantsOG00052
ParticipantsOG00140
ParticipantsOG00239
Title
Measurements
OG000
Seronegative- Serotype 2: 1 year post vaccination 3
ParticipantsOG00039
ParticipantsOG00135
ParticipantsOG00233
Title
Measurements
OG000
Seronegative- Serotype 3: Baseline
ParticipantsOG00052
ParticipantsOG00140
ParticipantsOG00241
Title
Measurements
OG000
Seronegative- Serotype 3: 28 days post vaccination 3
ParticipantsOG00052
ParticipantsOG00140
ParticipantsOG00239
Title
Measurements
OG000
Seronegative- Serotype 3: 1 year post injection 3
ParticipantsOG00039
ParticipantsOG00135
ParticipantsOG00233
Title
Measurements
OG000
Seronegative- Serotype 4: Baseline
ParticipantsOG00052
ParticipantsOG00140
ParticipantsOG00241
Title
Measurements
OG000
Seronegative- Serotype 4: 28 days post vaccination 3
ParticipantsOG00052
ParticipantsOG00140
ParticipantsOG00239
Title
Measurements
OG000
Seronegative- Serotype 4: 1 year post vaccination 3
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Units
Counts
Participants
OG000141
OG001144
OG002147
OG003140
OG004144
OG005144
Title
Denominators
Categories
Serotype 1: Baseline
ParticipantsOG000141
ParticipantsOG001144
ParticipantsOG002147
ParticipantsOG003140
ParticipantsOG004144
ParticipantsOG005144
Title
Measurements
OG00092.2(86.5 to 96.0)
OG00190.3(84.2 to 94.6)
OG00291.8(86.2 to 95.7)
OG003
Serotype 1: 28 days post vaccination 3
ParticipantsOG000137
ParticipantsOG001140
ParticipantsOG002145
ParticipantsOG003137
Serotype 1 : 1 year post vaccination 3
ParticipantsOG000137
ParticipantsOG001138
ParticipantsOG002143
ParticipantsOG003128
Serotype 2: Baseline
ParticipantsOG000141
ParticipantsOG001144
ParticipantsOG002147
ParticipantsOG003140
Serotype 2 : 28 days post vaccination 3
ParticipantsOG000137
ParticipantsOG001140
ParticipantsOG002145
ParticipantsOG003137
Serotype 2 : 1 year post vaccination 3
ParticipantsOG000137
ParticipantsOG001138
ParticipantsOG002143
ParticipantsOG003128
Serotype 3: Baseline
ParticipantsOG000141
ParticipantsOG001144
ParticipantsOG002147
ParticipantsOG003140
Serotype 3: 28 days post vaccination
ParticipantsOG000137
ParticipantsOG001140
ParticipantsOG002145
ParticipantsOG003137
Serotype 3 : 1 year post vaccination 3
ParticipantsOG000137
ParticipantsOG001138
ParticipantsOG002143
ParticipantsOG003128
Serotype 4: Baseline
ParticipantsOG000141
ParticipantsOG001144
ParticipantsOG002147
ParticipantsOG003140
Serotype 4: 28 days post vaccination 3
ParticipantsOG000137
ParticipantsOG001140
ParticipantsOG002145
ParticipantsOG003137
Serotype 4: 1 year post vaccination 3
ParticipantsOG000137
ParticipantsOG001138
ParticipantsOG002143
ParticipantsOG003128
OG002
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).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Units
Counts
Participants
OG00055
OG00159
OG00262
OG00353
OG00456
OG00553
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
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).
Units
Counts
Participants
OG000347
OG001347
OG002352
Title
Denominators
Categories
Pain
Title
Measurements
OG000109
OG001114
OG00297
Erythema
Title
Measurements
OG0004
OG0013
OG0023
Swelling
Title
Measurements
OG0002
OG0015
OG0025
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).
Units
Counts
Participants
OG000347
OG001347
OG002352
Title
Denominators
Categories
Post-vaccination 1: Pain
ParticipantsOG000347
ParticipantsOG001347
ParticipantsOG002352
Title
Measurements
OG00061
OG00161
OG00261
Post-vaccination 1: Erythema
ParticipantsOG000347
ParticipantsOG001347
ParticipantsOG002352
Title
Measurements
OG000
Post vaccination 1: Swelling
ParticipantsOG000347
ParticipantsOG001347
ParticipantsOG002352
Title
Measurements
OG000
Post-vaccination 2: Pain
ParticipantsOG000332
ParticipantsOG001328
ParticipantsOG002332
Title
Measurements
OG000
Post-vaccination 2: Erythema
ParticipantsOG000332
ParticipantsOG001328
ParticipantsOG002332
Title
Measurements
OG000
Post-vaccination 2: Swelling
ParticipantsOG000332
ParticipantsOG001328
ParticipantsOG002332
Title
Measurements
OG000
Post-vaccination 3: Pain
ParticipantsOG000325
ParticipantsOG001321
ParticipantsOG002324
Title
Measurements
OG000
Post-vaccination 3: Erythema
ParticipantsOG000325
ParticipantsOG001321
ParticipantsOG002324
Title
Measurements
OG000
Post-vaccination 3: Swelling
ParticipantsOG000325
ParticipantsOG001321
ParticipantsOG002324
Title
Measurements
OG000
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).
Units
Counts
Participants
OG000347
OG001347
OG002352
Title
Denominators
Categories
Fever
Title
Measurements
OG00029
OG00121
OG00231
Headache
Title
Measurements
OG000129
OG001122
OG002124
Malaise
Title
Measurements
OG000114
OG00198
OG002102
Myalgia
Title
Measurements
OG000110
OG00192
OG00286
Asthenia
Title
Measurements
OG00098
OG00180
OG00271
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).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Units
Counts
Participants
OG00055
OG00159
OG00262
OG00353
OG00454
OG00552
Title
Denominators
Categories
Pain
Title
Measurements
OG0006
OG0017
OG00211
OG0037
OG00412
OG00510
Erythema
Title
Measurements
OG0000
OG0010
OG0020
OG003
Swelling
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Units
Counts
Participants
OG00055
OG00159
OG00262
OG00353
OG00454
OG00552
Title
Denominators
Categories
Fever
ParticipantsOG00055
ParticipantsOG00159
ParticipantsOG00262
ParticipantsOG00353
ParticipantsOG00454
ParticipantsOG00551
Title
Measurements
OG0001
OG0010
OG0021
OG003
Headache
ParticipantsOG00055
ParticipantsOG00159
ParticipantsOG00262
ParticipantsOG00353
Malaise
ParticipantsOG00055
ParticipantsOG00159
ParticipantsOG00262
ParticipantsOG00353
Myalgia
ParticipantsOG00055
ParticipantsOG00159
ParticipantsOG00262
ParticipantsOG00353
Asthenia
ParticipantsOG00055
ParticipantsOG00159
ParticipantsOG00262
ParticipantsOG00353
Units
Counts
Participants
OG000348
OG001348
OG002352
Title
Denominators
Categories
Title
Measurements
OG00073
OG00194
OG00275
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Units
Counts
Participants
OG00055
OG00159
OG00262
OG00353
OG00456
OG00553
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG0025
OG0033
OG0042
OG0054
OG002
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).
Units
Counts
Participants
OG000348
OG001348
OG002352
Title
Denominators
Categories
SAE
Title
Measurements
OG00014
OG00126
OG00218
Serious AESI
Title
Measurements
OG0000
OG0010
OG0020
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 1 year post last dose in STAGE-I (i.e., at Month 24).
Participants from Group 1 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 2 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Participants from Group 3 who received vaccination in STAGE-I and were seropositive at baseline received a booster injection of CYD dengue vaccine in STAGE-II at 2 years post last dose in STAGE-I (i.e., at Month 36).
Units
Counts
Participants
OG00055
OG00159
OG00262
OG00353
OG00456
OG00553
Title
Denominators
Categories
SAE
Title
Measurements
OG0003
OG0010
OG0022
OG0032
OG0040
OG0051
Serious AESI
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
1 events
1 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0081 events1 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0071 events1 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0041 events1 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0071 events1 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
1 events
1 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0041 events1 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
1 events
1 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
0 events
0 affected
55 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected59 at risk
EG0060 events0 affected56 at risk
EG0070 events0 affected62 at risk
EG0080 events0 affected53 at risk
1 events
1 affected
55 at risk
EG0042 events2 affected53 at risk
EG0050 events0 affected59 at risk
EG0062 events2 affected56 at risk
EG0071 events1 affected62 at risk
EG0080 events0 affected53 at risk
6 events
6 affected
55 at risk
EG0047 events7 affected53 at risk
EG0057 events7 affected59 at risk
EG00612 events12 affected56 at risk
EG00711 events11 affected62 at risk
EG00810 events10 affected53 at risk
5 events
5 affected
55 at risk
EG0047 events7 affected53 at risk
EG0059 events9 affected59 at risk
EG0069 events9 affected56 at risk
EG0077 events7 affected62 at risk
EG0085 events5 affected53 at risk
5 events
5 affected
55 at risk
EG0049 events9 affected53 at risk
EG0058 events8 affected59 at risk
EG00612 events12 affected56 at risk
EG0079 events9 affected62 at risk
EG0086 events6 affected53 at risk
5 events
5 affected
55 at risk
EG0047 events7 affected53 at risk
EG00511 events11 affected59 at risk
EG00612 events12 affected56 at risk
EG0077 events7 affected62 at risk
EG0087 events7 affected53 at risk
870
(758 to 1000)
602
(529 to 686)
507
(451 to 570)
512
(411 to 638)
747
(622 to 897)
444
(376 to 525)
241
(208 to 279)
497
(410 to 602)
OG001586(482 to 714)
OG002735(589 to 916)
259
(200 to 336)
OG001279(213 to 365)
OG002331(252 to 435)
172
(138 to 214)
OG001202(163 to 252)
OG002181(147 to 222)
567
(482 to 666)
OG001628(532 to 741)
OG002734(614 to 878)
470
(380 to 582)
OG001457(364 to 574)
OG002500(402 to 623)
163
(131 to 202)
OG001180(145 to 222)
OG002169(138 to 207)
432
(373 to 500)
OG001446(383 to 519)
OG002505(428 to 595)
294
(240 to 361)
OG001288(235 to 354)
OG002258(213 to 312)
86.7
(71.4 to 105)
OG00183.8(69.9 to 100)
OG00281.2(67.7 to 97.4)
429
(380 to 484)
OG001441(392 to 496)
OG002546(475 to 629)
203
(176 to 235)
OG001192(164 to 226)
OG002177(150 to 210)
834
(713 to 975)
OG001877(737 to 1043)
OG0021201(1007 to 1431)
498
(406 to 611)
OG001512(411 to 638)
OG002618(500 to 764)
331
(279 to 394)
OG001326(271 to 393)
OG002293(247 to 347)
879
(775 to 997)
OG001870(758 to 1000)
OG0021046(912 to 1201)
815
(702 to 947)
OG001747(622 to 897)
OG002798(676 to 942)
310
(263 to 367)
OG001290(241 to 349)
OG002269(227 to 319)
620
(545 to 704)
OG001602(529 to 686)
OG002694(604 to 797)
477
(407 to 558)
OG001444(376 to 525)
OG002390(338 to 450)
147
(124 to 174)
OG001123(104 to 144)
OG002118(100 to 140)
527
(467 to 595)
OG001507(451 to 570)
OG002581(507 to 666)
263
(230 to 302)
OG001241(208 to 279)
OG002227(194 to 265)
5.00
(NA to NA)
The 95% CI was not computable as the standard deviation of the sample was 0, since all participants had the same value.
OG0015.57(4.65 to 6.67)
OG0025.49(4.75 to 6.34)
32.4
(23.1 to 45.6)
OG00134.3(23.8 to 49.4)
OG00220.2(12.0 to 34.1)
10.4
(7.12 to 15.1)
OG0019.01(6.30 to 12.9)
OG0028.04(5.86 to 11.0)
5.00
(NA to NA)
The 95% CI was not computable as the standard deviation of the sample was 0, since all participants had the same value.
OG0016.47(4.43 to 9.45)
OG0025.86(4.99 to 6.89)
56.2
(40.1 to 78.7)
OG00163.0(37.5 to 106)
OG00255.2(27.8 to 110)
31.3
(20.2 to 48.6)
OG00128.7(17.3 to 47.7)
OG00230.9(17.5 to 54.5)
5.00
(NA to NA)
The 95% CI was not computable as the standard deviation of the sample was 0, since all participants had the same value.
OG0015.69(4.86 to 6.66)
OG0026.09(5.05 to 7.34)
64.2
(48.6 to 84.9)
OG00153.7(36.1 to 80.0)
OG00249.5(30.1 to 81.5)
27.5
(17.4 to 43.5)
OG00125.3(15.8 to 40.3)
OG00221.8(13.6 to 35.0)
5.00
(NA to NA)
The 95% CI was not computable as the standard deviation of the sample was 0, since all participants had the same value.