Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
Conditions
Keywords
Dengue virus, Dengue fever, Dengue Hemorrhagic fever, Dengue diseases, Dengue vaccine
Brief summary
The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease. Primary Objectives: * To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine. * To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years). * To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).
Detailed description
Participants were randomized to receive either three injections of CYD dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively.
Interventions
BIOLOGICALCYD Dengue Vaccine Serotypes 1, 2, 3, and 4
0.5 mL, Subcutaneous (SC)
BIOLOGICALPneumococcal polysaccharide vaccine
0.5 mL, SC
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The observer-blind design was implemented. The person who performed vaccinations knew which product was administered while neither the participant nor the Investigator in charge of safety evaluation knew which product was injected. To maintain the blind and minimize any potential bias, the control group used the same route and schedule as the study vaccine.
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 2 to 11 years on the day of inclusion. * Participant in good health, based on medical history, physical examination and laboratory parameters. * Provision of Assent Form signed by the participants (for participants \>=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent\[s\]). * Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures. * For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination. * Documented receipt of yellow fever vaccine since at least one month before the first vaccination.
Exclusion criteria
: * Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * For a female participant of child-bearing potential (girls post-menarche), known pregnancy. * For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening. * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the trial. * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. * Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances. * Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine. * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. * Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures. * Receipt of any blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * Planned receipt of any vaccine in the 4 weeks following the first trial vaccination. * Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening. * Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening. * Known previous vaccination with pneumococcal polysaccharide vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3 | Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities. |
| Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3 | Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities. |
| Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3 | Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1 and 28 days Post-Injection 2 and 3 | Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer \>= 10 1/dilution. |
| Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1 and 28 days Post-Injection 2 and 3 | Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution. |
| Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1 and 28 days Post-Injection 2 and 3 | Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution. |
| Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution. |
| Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>= 10 1/dilution. |
| Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution. |
| Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution. |
| Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | Pre-Injection 1 and 28 days Post-Injection 2 and 3 | Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>= 10 1/dilution. |
| Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | Pre-Injection 1 and 28 days Post-Injection 2 and 3 | Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution. |
| Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Pre-Injection 1 and 28 days Post-Injection 2 and 3 | GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years. |
| Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Injection 1 and 28 days Post-Injection 1 | Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years. |
| GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Injection 1 and 28 days Post-Injection 1 | GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years. |
| GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 | GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years. |
| Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | Pre-Injection 1 and 28 days Post-Injection 2 and 3 | Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution. |
| Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution. |
| Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3 | Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution. |
Countries
Peru
Participant flow
Recruitment details
Study participants were enrolled from 26 September 2008 to 16 August 2010 at 1 clinical site in Peru.
Pre-assignment details
A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study. Two participants were not vaccinated and were excluded from the Full analysis set and Safety analysis set.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Group Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). | 199 |
| Control Group Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). | 99 |
| Total | 298 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Enrolled but not treated | 1 | 1 |
| Overall Study | Other adverse event | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 13 | 6 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 6.4 years STANDARD_DEVIATION 2.8 | 6.4 years STANDARD_DEVIATION 2.9 | 6.4 years STANDARD_DEVIATION 2.9 |
| Age, Customized 2 to 5 years | 100 Participants | 50 Participants | 150 Participants |
| Age, Customized 6 to 11 years | 99 Participants | 49 Participants | 148 Participants |
| Sex: Female, Male Female | 98 Participants | 53 Participants | 151 Participants |
| Sex: Female, Male Male | 101 Participants | 46 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 199 | 0 / 99 |
| other Total, other adverse events | 71 / 199 | 29 / 99 |
| serious Total, serious adverse events | 2 / 199 | 4 / 99 |
Outcome results
Primary
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Population: Analysis was performed on Safety analysis set which included all participants who received at least 1 dose of dengue or control vaccine. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 1 (2-11 years) | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 2 (2-11 years) | 2.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 1 (2-11 years) | 19.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj.1 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 1 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 1 (2-11 years) | 20.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 1 (2-11 years) | 13.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 3 (2-11 years) | 17.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 1 (2-11 years) | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 1 (2-11 years) | 5.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 2 (2-11 years) | 19.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 3 (2-11 years) | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 2 (2-11 years) | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 1 (2-11 years) | 3.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 2 (2-11 years) | 22.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 3 (2-11 years) | 4.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 2 (2-11 years) | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling; Post-Inj.1(2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 2 (2-11 years) | 18.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj.3 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 2 (All ages) | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 1 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 2 (2-11 years) | 14.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 3 (2-11 years) | 3.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 2 (2-11 years) | 1.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 2 (2-11 years) | 19.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 2 (2-11 years) | 11.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling;Post-Inj.3 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 2 (2-11 years) | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 3 (2-11 years) | 16.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 3 (2-11 years) | 18.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 1 (2-11 years) | 31.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 3 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 2 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 3 (2-11 years) | 18.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 1 (2-11 years) | 7.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 3 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 1 (2-11 years) | 35.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 2 (2-11 years) | 4.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 3 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 1 (2-11 years) | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 3 (2-11 years) | 13.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 3 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj.2 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 3 (2-11 years) | 10.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 1 (2-11 years) | 33.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 3 (2-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling;Post-Inj.2 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 3 (2-11 years) | 1.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 3 (2-11 years) | 26.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 1 (2-11 years) | 17.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 1 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 1 (2-11 years) | 4.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj.1 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 1 (2-11 years) | 5.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling; Post-Inj.1(2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 2 (2-11 years) | 17.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 2 (2-11 years) | 1.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj.2 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 2 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling;Post-Inj.2 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 3 (2-11 years) | 32.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 3 (2-11 years) | 2.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 3 (2-11 years) | 11.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj.3 (2-11 years) | 3.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 3 (2-11 years) | 8.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling;Post-Inj.3 (2-11 years) | 3.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 1 (2-11 years) | 10.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 1 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 1 (2-11 years) | 16.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 1 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 1 (2-11 years) | 23.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 1 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 1 (2-11 years) | 13.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 1 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 1 (2-11 years) | 13.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 1 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 2 (2-11 years) | 16.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 2 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 2 (2-11 years) | 19.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 2 (2-11 years) | 1.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 2 (2-11 years) | 16.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 2 (All ages) | 2.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 2 (2-11 years) | 10.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 2 (2-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 2 (2-11 years) | 7.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 2 (2-11 years) | 1.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 3 (2-11 years) | 22.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 3 (2-11 years) | 3.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 3 (2-11 years) | 27.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 3 (2-11 years) | 3.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 3 (2-11 years) | 23.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 3 (2-11 years) | 2.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 3 (2-11 years) | 2.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 3 (2-11 years) | 16.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 2 (2-11 years) | 1.1 Percentage of participants |
Primary
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Population: Analysis was performed on Safety analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 1 (2-5 years) | 11.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 1 (2-5 years) | 12.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 3 (2-5 years) | 14.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 2 (2-5 years) | 17.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 1 (2-5 years) | 13.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 3 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 1 (2-5 years) | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 3 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 2 (2-5 years) | 23.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 3 (2-5 years) | 3.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 2 (2-5 years) | 14.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj. 3 (2-5 years | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 2 (2-5 years) | 15.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 2 (2-5 years) | 1.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 3 (2-5 years) | 3.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 2 (2-5 years) | 9.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 2 (2-5 years) | 4.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 2 (2-5 years) | 1.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling;Post-Inj. 3 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 2 (2-5 years) | 9.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 1 (2-5 years) | 6.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 2 (2-5 years) | 1.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 1 (2-5 years) | 36.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 3 (2-5 years) | 16.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 3 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 1 (2-5 years) | 4.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 3 (2-5 years) | 6.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain: Post-Inj.1 (2-5 years) | 19.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 3 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 1 (2-5 years) | 23.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 3 (2-5 years) | 6.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 2 (2-5 years) | 2.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 3 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 1 (2-5 years) | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 3 (2-5 years) | 6.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling;Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 3 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 1 (2-5 years) | 33.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 3 (2-5 years) | 4.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling;Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 1 (2-5 years) | 1.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain: Post-Inj.1 (2-5 years) | 16.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 1 (2-5 years) | 6.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 1 (2-5 years) | 8.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling;Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 2 (2-5 years) | 15.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 2 (2-5 years) | 2.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling;Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 3 (2-5 years) | 23.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 3 (2-5 years) | 4.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 3 (2-5 years) | 9.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema;Post-Inj. 3 (2-5 years | 2.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 3 (2-5 years) | 7.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling;Post-Inj. 3 (2-5 years) | 2.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 1 (2-5 years) | 16.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 1 (2-5 years) | 8.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 1 (2-5 years) | 26.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 1 (2-5 years) | 10.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 1 (2-5 years) | 12.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 1 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 2 (2-5 years) | 17.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 2 (2-5 years) | 6.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 2 (2-5 years) | 13.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 2 (2-5 years) | 2.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 2 (2-5 years) | 6.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 2 (2-5 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 2 (2-5 years) | 8.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 2 (2-5 years) | 2.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 3 (2-5 years) | 26.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 3 (2-5 years) | 7.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 3 (2-5 years) | 18.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 3 (2-5 years) | 2.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 3 (2-5 years) | 23.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 3 (2-5 years) | 2.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 3 (2-5 years) | 20.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 3 (2-5 years) | 2.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 3 (2-5 years) | 23.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 3 (2-5 years) | 2.3 Percentage of participants |
Primary
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Time frame: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Population: Analysis was performed on Safety analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 2 (6-11 years) | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 1 (6-11 years) | 34.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 2 (6-11 years) | 21.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 3 (6-11 years) | 19.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 1 (6-11 years) | 26.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 2 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 1 (6-11 years) | 14.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj.1 (6-11 years) | 22.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 2 (6-11 years) | 4.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 2 (6-11 years) | 15.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling; Post-Inj.3(6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 2 (6-11 years) | 30.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling; Post-Inj.2(6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 2 (6-11 years) | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 2 (6-11 years) | 20.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 3 (6-11 years) | 20.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 2 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 1 (6-11 years) | 26.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 2 (6-11 years) | 19.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 3 (6-11 years) | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 2 (6-11 years) | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 1 (6-11 years) | 4.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 2 (6-11 years) | 12.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema; Post-Inj.3(6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 2 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 2 (6-11 years) | 2.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 3 (6-11 years) | 3.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 3 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema; Post-Inj.1(6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 3 (6-11 years) | 30.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 3 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 1 (6-11 years) | 5.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 3 (6-11 years) | 26.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 1 (6-11 years) | 3.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 3 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 3 (6-11 years) | 5.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 3 (6-11 years) | 19.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 1 (6-11 years) | 48.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 3 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling; Post-Inj.1(6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 3 (6-11 years) | 15.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 3 (6-11 years) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema; Post-Inj.2(6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 3 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema; Post-Inj.2(6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 2 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 3 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 1 (6-11 years) | 16.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 2 (6-11 years) | 14.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj.1 (6-11 years) | 18.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 1 (6-11 years) | 2.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema; Post-Inj.1(6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 1 (6-11 years) | 2.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling; Post-Inj.1(6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 2 (6-11 years) | 19.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Pain; Post-Inj. 2 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 2 (6-11 years) | 2.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling; Post-Inj.2(6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Pain; Post-Inj. 3 (6-11 years) | 40.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Erythema; Post-Inj. 3 (6-11 years) | 12.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema; Post-Inj.3(6-11 years) | 4.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Inj. site Swelling; Post-Inj. 3 (6-11 years) | 10.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling; Post-Inj.3(6-11 years) | 4.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 1 (6-11 years) | 4.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 1 (6-11 years) | 24.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 1 (6-11 years) | 20.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 1 (6-11 years) | 14.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 1 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 2 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 2 (6-11 years) | 31.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 2 (6-11 years) | 2.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 2 (6-11 years) | 19.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 2 (6-11 years) | 2.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 2 (6-11 years) | 14.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 2 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 2 (6-11 years) | 6.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Inj. 2 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Inj. 3 (6-11 years) | 19.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Inj. 3 (6-11 years) | 0.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Inj. 3 (6-11 years) | 36.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Inj. 3 (6-11 years) | 4.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Inj. 3 (6-11 years) | 23.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Inj. 3 (6-11 years) | 2.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Inj. 3 (6-11 years) | 31.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Inj. 3 (6-11 years) | 2.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Inj. 3 (6-11 years) | 10.6 Percentage of participants |
Secondary
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, 2-5 years | 16.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, All | 178 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, 2-5 years | 171 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, All | 144 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, 2-5 years | 214 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, All | 14.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, 2-5 years | 7.76 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, All | 184 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, 2-5 years | 165 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, All | 16.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, 2-5 years | 223 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, 2-5 years | 16.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, 6-11 years | 18.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 3, All | 179 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, 6-11 years | 116 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, 2-5 years | 135 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 3, 6-11 years | 157 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, All | 155 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, 6-11 years | 17.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 3, 2-5 years | 205 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, 6-11 years | 168 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, All | 151 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, 6-11 years | 163 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, 2-5 years | 11.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, 6-11 years | 16.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, All | 190 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, 6-11 years | 141 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, 2-5 years | 135 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, 6-11 years | 171 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, All | 125 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, 6-11 years | 8.50 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, 2-5 years | 195 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, 6-11 years | 127 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, All | 8.12 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, 6-11 years | 152 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, All | 17.4 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, 6-11 years | 15.0 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, All | 22.8 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, All | 26.4 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 3, All | 38.1 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, All | 18.2 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, All | 17.3 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, All | 21.6 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, All | 21.8 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, All | 26.6 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, All | 36.2 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, All | 8.94 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, All | 12.8 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, All | 16.7 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, 2-5 years | 16.2 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, 2-5 years | 19.0 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 3, 2-5 years | 31.3 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, 2-5 years | 13.9 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, 2-5 years | 13.2 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, 2-5 years | 21.8 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, 2-5 years | 16.7 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, 2-5 years | 26.5 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, 2-5 years | 35.0 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, 2-5 years | 9.02 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, 2-5 years | 14.4 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, 2-5 years | 18.7 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, 6-11 years | 32.3 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, 6-11 years | 36.2 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 3, 6-11 years | 45.8 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, 6-11 years | 24.0 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, 6-11 years | 22.3 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, 6-11 years | 21.4 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, 6-11 years | 28.6 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, 6-11 years | 26.6 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, 6-11 years | 37.3 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, 6-11 years | 8.87 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, 6-11 years | 11.4 Titers (1/dilution) |
Secondary
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, All | 214 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, 2-5 years | 19.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, All | 99.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, 2-5 years | 11.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 2, All | 11.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 1, 2-5 years | 37.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, All | 7.52 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 2, 2-5 years | 19.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj.1, All | 43.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, 2-5 years | 129 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj.1, All | 87.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 3, 2-5 years | 26.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, All | 21.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, 2-5 years | 108 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 2, All | 21.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, 2-5 years | 7.04 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 3, All | 64.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 1, 2-5 years | 114 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, All | 158 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 3, All | 11.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, 2-5 years | 200 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 3, All | 39.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 3, 2-5 years | 39.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, All | 18.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, 2-5 years | 176 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, All | 147 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, 6-11 years | 17.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, All | 22.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 1, 6-11 years | 41.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, 2-5 years | 20.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 2, 6-11 years | 27.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 3, All | 254 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, 6-11 years | 165 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 1, 2-5 years | 44.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 3, 6-11 years | 63.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, All | 13.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1;28 days Post-Inj. 3, 6-11 years | 207 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 2, 2-5 years | 31.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, 6-11 years | 8.57 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 2, All | 29.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 1, 6-11 years | 18.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, 2-5 years | 281 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 2, 6-11 years | 13.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj.1, All | 41.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, 6-11 years | 26.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 3, 2-5 years | 65.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 3, 6-11 years | 14.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, All | 7.55 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, 6-11 years | 25.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 3, 2-5 years | 315 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, 6-11 years | 14.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 2, All | 22.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 1, 6-11 years | 45.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 2, 2-5 years | 22.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 2, 6-11 years | 25.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, 2-5 years | 6.66 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, 6-11 years | 126 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, 6-11 years | 91.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 3, 6-11 years | 35.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 1, 2-5 years | 12.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, All | 128 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, 6-11 years | 8.03 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 2, 2-5 years | 10.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 1, 6-11 years | 68.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj.1, All | 15.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 2, 6-11 years | 20.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, 2-5 years | 17.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, 6-11 years | 126 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 3, All | 31.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 3, 6-11 years | 39.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 3, 2-5 years | 9.03 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, 6-11 years | 125 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 1, 6-11 years | 18.3 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, 6-11 years | 7.82 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, All | 23.9 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj.1, All | 22.8 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 2, All | 26.0 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, All | 26.1 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 3, All | 28.9 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 3, All | 35.3 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, All | 7.76 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj.1, All | 7.51 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 2, All | 7.32 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, All | 6.99 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 3, All | 7.26 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, All | 7.73 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, All | 16.3 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj.1, All | 15.3 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 2, All | 15.4 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, All | 15.5 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 3, All | 14.0 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, All | 16.0 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, All | 8.08 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj.1, All | 7.84 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 2, All | 7.73 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, All | 7.81 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 3, All | 7.49 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, All | 8.54 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, 2-5 years | 18.6 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 1, 2-5 years | 19.6 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 2, 2-5 years | 19.7 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, 2-5 years | 20.9 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 3, 2-5 years | 22.1 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 3, 2-5 years | 35.9 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, 2-5 years | 6.48 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 1, 2-5 years | 6.73 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 2, 2-5 years | 6.28 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, 2-5 years | 6.13 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 3, 2-5 years | 6.68 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, 2-5 years | 7.93 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, 2-5 years | 12.2 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 1, 2-5 years | 12.9 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 2, 2-5 years | 12.3 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, 2-5 years | 12.6 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 3, 2-5 years | 12.2 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, 2-5 years | 15.3 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, 2-5 years | 7.74 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 1, 2-5 years | 8.43 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 2, 2-5 years | 7.64 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, 2-5 years | 8.22 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 3, 2-5 years | 7.97 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 3, 2-5 years | 9.37 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 1, 6-11 years | 31.0 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 1, 6-11 years | 26.7 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 2, 6-11 years | 33.9 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; 28 days Post-Inj. 2, 6-11 years | 32.4 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1; Pre-Inj. 3, 6-11 years | 37.2 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 1;28 days Post-Inj. 3, 6-11 years | 34.7 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 1, 6-11 years | 9.32 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 1, 6-11 years | 8.40 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 2, 6-11 years | 8.50 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 2, 6-11 years | 7.92 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; Pre-Inj. 3, 6-11 years | 7.85 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 2; 28 days Post-Inj. 3, 6-11 years | 7.55 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 1, 6-11 years | 21.8 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 2, 6-11 years | 19.2 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 2, 6-11 years | 19.1 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; Pre-Inj. 3, 6-11 years | 15.8 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 3; 28 days Post-Inj. 3, 6-11 years | 16.7 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 1, 6-11 years | 8.43 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 1, 6-11 years | 7.28 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 2, 6-11 years | 7.82 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; 28 days Post-Inj. 2, 6-11 years | 7.44 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo | Serotype 4; Pre-Inj. 3, 6-11 years | 7.06 Titers (1/dilution) |
Secondary
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Time frame: Pre-Injection 1 and 28 days Post-Injection 1
Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; All participants | 32.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; All participants | 43.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; 2-5 years | 15.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; 2-5 years | 22.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; 6-11 years | 66.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; 6-11 years | 82.9 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; 6-11 years | 63.9 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; All participants | 36.0 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; 2-5 years | 21.2 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; All participants | 36.0 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; 6-11 years | 61.8 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; 2-5 years | 20.5 Titers (1/dilution) |
Secondary
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 3 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 1 | 80.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 1 | 19.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 3 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 1 | 52.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 3 | 79.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 2 | 38.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 1 | 29.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 2 | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 2 | 69.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 3 | 67.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 1 | 66.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 3 | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 1 | 32.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 1 | 10.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 1 | 37.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 2 | 27.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 3 | 75.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 2 | 66.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 2 | 49.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 3 | 33.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 3 | 88.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 3 | 15.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 1 | 38.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 3 | 13.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 1 | 40.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 1 | 40.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 2 | 40.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 2 | 42.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 3 | 42.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 3 | 48.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 1 | 38.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 2 | 39.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 2 | 40.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 3 | 39.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 3 | 43.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 1 | 24.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 1 | 25.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 2 | 22.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 2 | 21.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 3 | 25.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 3 | 25.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 1 | 13.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 1 | 12.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 2 | 16.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 2 | 10.9 Percentage of participants |
Secondary
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 1 | 37.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 3 | 99.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 1 | 31.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 2 | 99.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 3 | 99.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 1 | 29.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 2 | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 3 | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 1 | 17.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 2 | 90.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 3 | 94.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 2 | 29.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 1 | 48.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 1 | 37.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 2 | 57.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 1 | 19.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 3 | 73.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 2 | 41.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 1 | 41.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 3 | 39.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 2 | 41.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 3 | 46.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 3 | 52.8 Percentage of participants |
Secondary
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Population: Analysis was performed on Full analysis set which included all the participants present at visit 1 and who received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj.1 | 68.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 2 | 57.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 68.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 2 | 51.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 3 | 82.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 3 | 72.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 79.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 29.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 1 | 55.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 2 | 32.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 2 | 42.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 30.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 3 | 74.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 14.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 3 | 35.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 17.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 1 | 74.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 1 | 40.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 3 | 18.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 3 | 39.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 1 | 21.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 2 | 20.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 16.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 3 | 20.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 20.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 38.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj.1 | 38.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 2 | 39.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 40.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 43.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 18.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 1 | 18.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 2 | 20.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 19.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 23.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 38.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 1 | 37.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 2 | 39.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 39.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 3 | 41.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 46.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 21.2 Percentage of participants |
Secondary
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer \>= 10 1/dilution.
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 96.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 31.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 30.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 94.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 35.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 19.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 98.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 35.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 48.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 46.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 22.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 43.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 51.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 47.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 41.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 48.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 36.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 67.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 39.1 Percentage of participants |
Secondary
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>= 10 1/dilution.
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 1 | 28.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 1 | 78.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 2 | 67.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 3 | 90.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 1 | 31.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 1 | 65.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 2 | 46.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 3 | 75.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 1 | 17.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 1 | 48.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 2 | 33.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 2 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 3 | 65.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 3 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 1 | 9.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 1 | 31.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 2 | 25.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 2 | 63.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 3 | 27.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 3 | 77.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 3 | 13.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 1 | 34.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 1 | 24.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 1 | 35.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 1 | 8.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 2 | 32.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 1 | 27.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 2 | 33.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 2 | 8.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; Pre-Inj. 3 | 36.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 2 | 19.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 1 positive serotype; 28 days Post-Inj. 3 | 44.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 1 | 10.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 1 | 32.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 2 | 20.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 1 | 35.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; 28 days Post-Inj. 3 | 18.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 2 | 32.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; Pre-Inj. 3 | 27.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 2 | 33.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | All 4 positive serotypes; Pre-Inj. 2 | 10.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; Pre-Inj. 3 | 34.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 3 positive serotypes; 28 days Post-Inj. 3 | 30.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | At least 2 positive serotypes; 28 days Post-Inj. 3 | 39.5 Percentage of participants |
Secondary
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>= 10 1/dilution.
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 1 | 28.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 1 | 30.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 2 | 97.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 1 | 39.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 3 | 100 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 1 | 14.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 2 | 90.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 3 | 96.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 3 | 100.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 3 | 37.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 1 | 42.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 2 | 64.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 3 | 74.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 1 | 36.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 2 | 33.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 3 | 44.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 1 | 34.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 2 | 33.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 3 | 41.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 2 | 26.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 1 | 16.0 Percentage of participants |
Secondary
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 3 | 28.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 3 | 72.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 77.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 1 | 62.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 28.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 2 | 45.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 2 | 60.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 14.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 3 | 70.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 1 | 32.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 2 | 38.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 13.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 2 | 29.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 1 | 74.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 97.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 64.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 3 | 87.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 30.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 1 | 54.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 27.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 16.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 32.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 2 | 17.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 32.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 1 | 33.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 2 | 31.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 31.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 3 | 36.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 44.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 1 | 16.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 2 | 15.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 11.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 3 | 18.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 20.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 1 | 35.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 2 | 32.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 33.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 3 | 34.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 39.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 18.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 1 | 22.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 20.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 3 | 22.7 Percentage of participants |
Secondary
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 35.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 96.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 30.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 30.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 16.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 96.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 97.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 97.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 100.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 46.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 30.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 31.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 41.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 38.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 37.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 38.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 53.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 65.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 22.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 35.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 44.2 Percentage of participants |
Secondary
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 1 | 30.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 1 | 82.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 2 | 71.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 3 | 87.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 3 | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 1 | 33.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 1 | 68.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 2 | 52.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 3 | 75.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 3 | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 1 | 22.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 1 | 57.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 2 | 42.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 2 | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 3 | 69.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 3 | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 1 | 12.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 1 | 43.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 2 | 29.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 2 | 68.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 3 | 39.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 3 | 80.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 3 | 12.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 1 | 46.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 1 | 24.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 1 | 44.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 1 | 18.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 2 | 48.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 1 | 23.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 2 | 51.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 2 | 12.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 3 | 48.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 2 | 25.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 3 | 52.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 1 | 14.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 1 | 44.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 2 | 23.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 1 | 42.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 3 | 13.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 2 | 46.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 3 | 23.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 2 | 46.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 2 | 21.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 3 | 44.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 3 | 21.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 3 | 47.8 Percentage of participants |
Secondary
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 1 | 35.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 3 | 99.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 1 | 32.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 2 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 3 | 99.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 1 | 31.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 2 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 3 | 96.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 1 | 20.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 2 | 91.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 3 | 91.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 2 | 31.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; Pre-Inj. 1 | 55.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; Pre-Inj. 1 | 40.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 2 | 51.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; Pre-Inj. 1 | 22.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 1 positive serotype; 28 days Post-Inj. 3 | 71.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 2 | 48.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; Pre-Inj. 1 | 46.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | All 4 positive serotypes; 28 days Post-Inj. 3 | 41.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 2 | 48.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 3 positive serotypes; 28 days Post-Inj. 3 | 50.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine | At least 2 positive serotypes; 28 days Post-Inj. 3 | 60.9 Percentage of participants |
Secondary
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Time frame: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 20.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 3 | 77.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 29.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 1 | 56.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 2 | 45.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 99.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 1 | 48.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 2 | 36.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 71.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 3 | 41.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 80.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 33.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj 1 | 74.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 2 | 58.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 3 | 75.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 15.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 1 | 73.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 2 | 55.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 95.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 3 | 78.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 97.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 3 | 14.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 44.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 18.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 44.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj 1 | 42.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 1 | 42.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 19.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 2 | 46.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 2 | 46.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 3 | 46.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 1 | 14.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 47.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 46.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 26.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 46.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 1 | 25.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 19.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 2 | 25.5 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 3 | 44.7 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 21.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 2 | 23.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 3 | 23.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 47.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 19.6 Percentage of participants |
Secondary
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
Time frame: Pre-Injection 1 and 28 days Post-Injection 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 30.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 92.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 94.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 32.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 96.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 34.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 22.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 97.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 2 | 36.2 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; Pre-Inj. 1 | 42.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; Pre-Inj. 1 | 55.1 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 2 | 46.8 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; Pre-Inj. 1 | 22.4 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 1; 28 days Post-Inj. 3 | 54.3 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 2 | 48.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; Pre-Inj. 1 | 44.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 4; 28 days Post-Inj. 3 | 50.0 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 2 | 48.9 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 3; 28 days Post-Inj. 3 | 69.6 Percentage of participants |
| Control Group | Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo | Dengue parental serotype 2; 28 days Post-Inj. 3 | 50.0 Percentage of participants |
Secondary
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Time frame: Pre-Injection 1 and 28 days Post-Injection 1
Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; All participants | 81.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; All participants | 86.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; 2-5 years | 68.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; 2-5 years | 76.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; 6-11 years | 94.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; 6-11 years | 95.9 Percentage of participants |
| Control Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; 6-11 years | 93.9 Percentage of participants |
| Control Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; All participants | 83.8 Percentage of participants |
| Control Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; 2-5 years | 72.9 Percentage of participants |
| Control Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; All participants | 83.2 Percentage of participants |
| Control Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | 28 days Post-Inj. 1; 6-11 years | 93.6 Percentage of participants |
| Control Group | Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo | Pre-Inj. 1; 2-5 years | 74.0 Percentage of participants |