Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus, Dengue Diseases
Conditions
Keywords
Dengue virus, Dengue fever, Dengue Hemorrhagic fever, Dengue diseases, Sanofi Pasteur's CYD Dengue Vaccine
Brief summary
Primary Objectives: * To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity. * To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period. * To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants. Secondary Objectives: * To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.
Detailed description
This was a multicenter trial involving three vaccinations one each at 0, 6 and 12 months over a period of 1 year, and a 4-year follow-up following the last vaccination.
Interventions
BIOLOGICALCYD Dengue vaccine
0.5 mL, Subcutaneous on Day 0, Months 6 and 12
BIOLOGICALNaCl + influenza virus or hepatitis A vaccine
0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
An observer-design for the first vaccination and a single-blind design for the second and third vaccination were chosen to minimize the bias of the vaccine evaluation. The Investigator in charge of safety evaluation, the Sponsor, and the participants/parents did not know which vaccine was administrated at the first visit. For the second and third vaccinations, the participants/parents did not know which vaccine was administered.
Eligibility
Sex/Gender
ALL
Age
2 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged from 2 to 45 years on the day of inclusion. * Participant in good health, based on medical history and physical examination. * Provision of informed consent form (and assent form for participants aged 6 to 12 years) signed by the participant and by the parent(s) or another legally acceptable representative for participants aged less than 21 years. * Participants and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures. * For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 4 weeks after the last vaccination.
Exclusion criteria
: * Febrile illness (temperature \>= 37.5°C) or moderate or severe acute illness/infection on the day of the first vaccination, according to Investigator judgment. * For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion. * Breast-feeding woman. * Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances. * Personal or family history of thymic pathology or myasthenia. * Previous hepatitis A vaccination (for children only). * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroid therapy. * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. * Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response. * 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 18 coming months. * 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. * Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * Current or past alcohol abuse or drug addiction that may interfere with the participants ability to comply with trial procedures. * Participant who plans to move to another country within the 18 coming months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Day 0 up to 14 days post-any and each injection | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions (2-11 years): Pain, incapacitating, unable to perform usual activities; Erythema and Swelling, \>=5 cm. Grade 3 Solicited injection site reactions (adolescents and adults: \>=12 years): Pain, significant; prevents daily activity; Erythema and Swelling: \>10 cm. Grade 3 Solicited systemic reactions (all participants): Fever, \>=39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity. |
| Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | Day 0 up to 14 days post-each injection | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. |
| Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3 | Seropositivity against each dengue virus serotype (parental strains) was assessed using a dengue plaque reduction neutralization test (PRNT) assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). |
| Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1 and 28 days Post-Injection 3 | Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). |
| Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1 and 28 days Post-Injection 3 | Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). |
| Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3 | GMTs against each serotype with the parental dengue virus strains were assessed using a dengue PRNT assay. |
| GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | Pre-Injection 1 and 28 days Post-Injection 3 | GMTs against each dengue virus serotype (parental strains) were assessed using a dengue PRNT assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay. |
| GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | GMTs against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. |
| Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers \>=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers \>=10 (1/dilution) against at least one dengue serotype at baseline. |
| Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers \<10 (1/dilution) against all dengue serotypes at baseline. |
| Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). |
| Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against each serotype with the dengue virus strain were assessed using a PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers \<10 (1/dilution) against all dengue serotypes at baseline. |
| Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers \>=10 (1/dilution) against at least one dengue serotype at baseline. |
| Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers \<10 (1/dilution) against all dengue serotypes at baseline. |
| Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers \>=10 (1/dilution) against at least one dengue serotype at baseline. |
| Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers \>=10 (1/dilution). |
| Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). |
| Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). |
| Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). |
| Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). |
| GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years) | GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay. |
Countries
Singapore
Participant flow
Recruitment details
Study participants were enrolled from 07 April 2009 to 08 October 2009 at 5 clinical sites in Singapore.
Pre-assignment details
A total of 1198 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Group Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively. | 898 |
| Placebo Group All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations. | 300 |
| Total | 1,198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 76 | 33 |
| Overall Study | Protocol Violation | 13 | 1 |
| Overall Study | Serious adverse event | 3 | 0 |
| Overall Study | Withdrawal by Subject | 15 | 11 |
Baseline characteristics
| Characteristic | Placebo Group | Total | CYD Dengue Vaccine Group |
|---|---|---|---|
| Age, Continuous | 21.7 Years STANDARD_DEVIATION 11.8 | 22.0 Years STANDARD_DEVIATION 11.9 | 22.1 Years STANDARD_DEVIATION 12 |
| Age, Customized 12-17 years | 46 Participants | 187 Participants | 141 Participants |
| Age, Customized 18-45 years | 174 Participants | 695 Participants | 521 Participants |
| Age, Customized 2-11 years | 80 Participants | 316 Participants | 236 Participants |
| Sex: Female, Male Female | 139 Participants | 610 Participants | 471 Participants |
| Sex: Female, Male Male | 161 Participants | 588 Participants | 427 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 898 | 0 / 300 |
| other Total, other adverse events | 481 / 898 | 198 / 300 |
| serious Total, serious adverse events | 43 / 898 | 13 / 300 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
GMTs against each serotype with the parental dengue virus strains were assessed using a dengue PRNT assay.
Time frame: Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3
Population: Analysis was performed on Per-Protocol analysis set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 72.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 2 | 90.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 8.45 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 3 | 18.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 1 | 28.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 1 | 10.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 2 | 29.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 46.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 2 | 70.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 2 | 50.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 3 | 39.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 9.06 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 100 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 2 | 12.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 6.93 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 1 | 17.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 1 | 65.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 8.20 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 2 | 47.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 2 | 19.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 3 | 47.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 3 | 24.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 99.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 2 | 22.4 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 7.66 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 2 | 9.48 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 2 | 8.00 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 8.23 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 1 | 7.09 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 2 | 7.85 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 2 | 7.91 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 3 | 7.40 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 8.93 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 8.48 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 1 | 7.39 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 3 | 6.98 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 8.88 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 8.93 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 1 | 9.56 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 2 | 11.1 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 2 | 10.5 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 3 | 8.23 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 9.52 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 6.84 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 1 | 6.31 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 2 | 7.91 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 3 | 6.04 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 2 | 9.79 Titers (1/dilution) |
Primary
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
GMTs against each dengue virus serotype (parental strains) were assessed using a dengue PRNT assay.
Time frame: Pre-Injection 1 and 28 days Post-Injection 3
Population: Analysis was performed on Per-Protocol analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 4; Post-Inj. 3 | 127 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 3; Pre-Inj. 1 | 6.86 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 4; Pre-Inj. 1 | 5.64 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 3; Post-Inj. 3 | 74.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 2; Pre-Inj. 1 | 5.85 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 4; Pre-Inj. 1 | 5.83 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 1; Pre-Inj. 1 | 5.33 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 4; Post-Inj. 3 | 80.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 4; Post-Inj. 3 | 101 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 1; Pre-Inj. 1 | 16.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 3; Pre-Inj. 1 | 6.24 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 1; Post-Inj. 3 | 59.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 1; Pre-Inj. 1 | 6.49 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 2; Pre-Inj. 1 | 17.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 2; Post-Inj. 3 | 95.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 2; Post-Inj. 3 | 72.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 1; Post-Inj. 3 | 28.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 3; Pre-Inj. 1 | 14.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 1; Post-Inj. 3 | 60.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 3; Post-Inj. 3 | 94.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 2; Pre-Inj. 1 | 7.47 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 4; Pre-Inj. 1 | 10.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 3; Post-Inj. 3 | 138 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 2; Post-Inj. 3 | 54.0 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 4; Pre-Inj. 1 | 5.08 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 3; Pre-Inj. 1 | 6.02 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 1; Pre-Inj. 1 | 5.44 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 1; Post-Inj. 3 | 6.32 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 2; Pre-Inj. 1 | 5.18 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 2; Post-Inj. 3 | 6.09 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 3; Post-Inj. 3 | 6.67 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 4; Pre-Inj. 1 | 5.42 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 2-11 years, CYD dengue Serotype 4; Post-Inj. 3 | 6.92 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 1; Pre-Inj. 1 | 5.47 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 1; Post-Inj. 3 | 6.56 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 2; Pre-Inj. 1 | 5.54 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 2; Post-Inj. 3 | 6.35 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 3; Pre-Inj. 1 | 6.83 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 3; Post-Inj. 3 | 8.32 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 12-17 years, CYD dengue Serotype 4; Post-Inj. 3 | 6.68 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 1; Pre-Inj. 1 | 18.5 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 1; Post-Inj. 3 | 18.3 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 2; Pre-Inj. 1 | 21.1 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 2; Post-Inj. 3 | 19.5 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 3; Pre-Inj. 1 | 17.5 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 3; Post-Inj. 3 | 16.3 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 4; Pre-Inj. 1 | 11.7 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | 18-45 years, CYD dengue Serotype 4; Post-Inj. 3 | 9.96 Titers (1/dilution) |
Primary
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions (2-11 years): Pain, incapacitating, unable to perform usual activities; Erythema and Swelling, \>=5 cm. Grade 3 Solicited injection site reactions (adolescents and adults: \>=12 years): Pain, significant; prevents daily activity; Erythema and Swelling: \>10 cm. Grade 3 Solicited systemic reactions (all participants): Fever, \>=39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.
Time frame: Day 0 up to 14 days post-any and each injection
Population: Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Swelling; Post- Injection 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Erythema; Post-Any Injection | 7.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema; Post-Any Inj. | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Swelling; Post-Any Injection | 4.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling; Post-Any Inj. | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Pain; Post-Injection 1 | 31.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Pain; Post- Injection 1 | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Erythema; Post-Injection 1 | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Erythema; Post- Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Swelling; Post-Injection 1 | 1.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Swelling; Post- Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Pain; Post-Injection 2 | 36.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Pain; Post- Injection 2 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Erythema; Post-Injection 2 | 3.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Erythema; Post- Injection 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Swelling; Post-Injection 2 | 1.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Pain; Post-Any Injection | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Pain; Post-Injection 3 | 34.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Pain; Post- Injection 3 | 0.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Erythema; Post- Injection 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Swelling; Post-Injection 3 | 2.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Swelling; Post- Injection 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Any Injection | 11.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Any Injection | 1.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Any Injection | 45.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Any Injection | 3.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Any Injection | 41.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Any Injection | 4.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Any Injection | 44.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Any Injection | 2.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Any Injection | 20.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Any Injection | 1.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Injection 1 | 4.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Injection 1 | 0.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Injection 1 | 30.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Injection 1 | 2.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Injection 1 | 25.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Injection 1 | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Injection 1 | 29.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Injection 1 | 1.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Injection 1 | 12.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Injection 1 | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Injection 2 | 3.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Injection 2 | 0.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Injection 2 | 22.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Injection 2 | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Injection 2 | 24.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Injection 2 | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Injection 2 | 9.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Injection 3 | 20.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Injection 3 | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Injection 3 | 18.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Injection 3 | 1.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Injection 3 | 21.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Injection 3 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Injection 3 | 8.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Injection 3 | 0.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Injection 2 | 19.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Injection 2 | 1.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Injection 2 | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Injection 3 | 4.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Injection 3 | 0.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Pain; Post-Any Injection | 53.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Erythema; Post-Injection 3 | 3.8 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Pain; Post-Any Injection | 2.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Injection 1 | 2.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Erythema; Post-Any Injection | 15.2 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Injection 3 | 0.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Erythema; Post-Any Inj. | 0.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Injection 1 | 0.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Swelling; Post-Any Injection | 8.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Injection 3 | 0.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Inj. site Swelling; Post-Any Inj. | 0.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Injection 1 | 27.3 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Pain; Post-Injection 1 | 21.9 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Injection 3 | 19.8 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Pain; Post- Injection 1 | 0.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Injection 1 | 1.3 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Erythema; Post-Injection 1 | 2.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Injection 1 | 0.3 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Erythema; Post- Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Injection 1 | 18.2 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Swelling; Post-Injection 1 | 1.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Injection 3 | 0.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Swelling; Post- Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Injection 1 | 0.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Pain; Post-Injection 2 | 54.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Injection 2 | 2.8 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Pain; Post- Injection 2 | 0.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Injection 1 | 19.2 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Erythema; Post-Injection 2 | 8.8 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Injection 3 | 17.3 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Erythema; Post- Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Injection 1 | 1.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Swelling; Post-Injection 2 | 3.5 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Injection 2 | 1.1 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Swelling; Post- Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Injection 1 | 6.1 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Pain; Post-Injection 3 | 50.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Injection 3 | 1.1 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Pain; Post- Injection 3 | 0.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Erythema; Post-Injection 3 | 9.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Any Injection | 7.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Erythema; Post- Injection 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Injection 3 | 26.3 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Swelling; Post-Injection 3 | 5.8 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Injection site Swelling; Post- Injection 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Injection 2 | 18.2 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Injection 2 | 21.8 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Fever; Post-Any Injection | 1.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Injection 3 | 0.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Headache; Post-Any Injection | 38.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Injection 2 | 1.1 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Headache; Post-Any Injection | 2.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Fever; Post-Injection 3 | 2.9 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Malaise; Post-Any Injection | 35.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Injection 2 | 29.5 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Malaise; Post-Any Injection | 2.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Injection 3 | 9.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Myalgia; Post-Any Injection | 43.8 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Injection 2 | 0.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Myalgia; Post-Any Injection | 2.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Injection site Pain; Post-Any Injection | 66.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Any Injection | 17.5 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Asthenia; Post-Injection 2 | 10.2 Percentage of participants |
| Placebo Group | Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo | Grade 3 Asthenia; Post-Any Injection | 0.7 Percentage of participants |
Primary
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each dengue virus serotype (parental strains) was assessed using a dengue plaque reduction neutralization test (PRNT) assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3
Population: Analysis was performed on Per-Protocol (PP) analysis set which included all participants who were vaccinated and had no protocol deviations. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 1 | 58.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 3 | 58.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 2 | 54.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 88.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 1 | 22.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 19.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 3 | 45.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 2 | 63.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 2 | 30.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 2 | 87.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 79.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 93.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 3 | 77.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 16.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 1 | 67.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 12.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 2 | 69.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 1 | 39.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 2 | 85.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 2 | 39.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 3 | 79.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 14.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 93.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 2 | 80.4 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 19.3 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 1 | 11.6 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 1 | 21.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 2 | 26.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 2 | 16.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 2 | 18.3 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 3 | 13.8 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 22.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 15.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 1 | 10.1 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 2 | 16.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 2 | 15.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 3 | 13.8 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 20.2 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 20.1 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 2 | 31.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 3 | 19.0 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 24.8 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 12.9 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 1 | 11.6 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 2 | 16.7 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 2 | 16.9 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 3 | 8.6 Percentage of participants |
| Placebo Group | Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 17.1 Percentage of participants |
Primary
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 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. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia.
Time frame: Day 0 up to 14 days post-each injection
Population: Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Asthenia, Post-Inj. 2 | 8.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Erythema, Post-Inj. 1 | 6.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Swelling, Post-Inj. 1 | 3.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Injection site Pain, Post- Inj. 1 | 28.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Erythema, Post- Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Swelling, Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Injection site Pain, Post- Inj. 1 | 30.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Erythema, Post- Inj. 1 | 0.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Swelling, Post-Inj. 1 | 0.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Injection site Pain, Post- Inj. 2 | 38.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Erythema, Post-Inj. 2 | 9.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Swelling, Post-Inj. 2 | 4.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Injection site Pain, Post- Inj. 2 | 29.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Erythema, Post- Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Swelling, Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Injection site Pain, Post- Inj. 2 | 38.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Erythema, Post- Inj. 2 | 1.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Swelling, Post-Inj. 2 | 0.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Injection site Pain, Post- Inj. 3 | 32.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Erythema, Post-Inj. 3 | 8.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Swelling, Post-Inj. 3 | 6.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Injection site Pain, Post- Inj. 3 | 26.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Erythema, Post- Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Swelling, Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Injection site Pain, Post- Inj. 3 | 38.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Erythema, Post- Inj. 3 | 2.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Swelling, Post-Inj. 3 | 1.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Fever, Post-Inj. 1 | 8.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Headache, Post-Inj. 1 | 39.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Malaise, Post-Inj. 1 | 26.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Myalgia, Post-Inj. 1 | 31.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Asthenia, Post-Inj. 1 | 15.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Fever, Post-Inj. 2 | 6.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Headache, Post-Inj. 2 | 21.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Malaise, Post-Inj. 2 | 21.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Myalgia, Post-Inj. 2 | 24.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Asthenia, Post-Inj. 2 | 7.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Fever, Post-Inj. 2 | 4.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Headache, Post-Inj. 2 | 19.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Fever, Post-Inj. 3 | 5.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Headache, Post-Inj. 3 | 21.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Headache, Post-Inj. 1 | 25.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Malaise, Post-Inj. 1 | 19.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Myalgia, Post-Inj. 1 | 23.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Asthenia, Post-Inj. 1 | 7.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Fever, Post-Inj. 1 | 7.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Malaise, Post-Inj. 1 | 29.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Myalgia, Post-Inj. 1 | 32.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Asthenia, Post-Inj. 1 | 13.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Fever, Post-Inj. 1 | 2.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Headache, Post-Inj. 1 | 29.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Malaise, Post-Inj. 2 | 16.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Myalgia, Post-Inj. 2 | 19.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Injection site Pain, Post-Inj. 1 | 33.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Fever, Post-Inj. 2 | 1.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Headache, Post-Inj. 2 | 24.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Malaise, Post-Inj. 2 | 18.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Myalgia, Post-Inj. 2 | 24.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Asthenia, Post-Inj. 2 | 10.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Fever, Post-Inj. 3 | 8.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Headache, Post-Inj. 3 | 17.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Malaise, Post-Inj. 3 | 18.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Myalgia, Post-Inj. 3 | 20.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Asthenia, Post-Inj. 3 | 7.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Headache, Post-Inj. 3 | 20.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Malaise, Post-Inj. 3 | 18.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Myalgia, Post-Inj. 3 | 14.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Asthenia, Post-Inj. 3 | 5.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Fever, Post-Inj. 3 | 2.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Malaise, Post-Inj. 3 | 17.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Myalgia, Post-Inj. 3 | 24.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Asthenia, Post-Inj. 3 | 9.6 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Myalgia, Post-Inj. 2 | 22.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Injection site Pain, Post-Inj. 1 | 30.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Asthenia, Post-Inj. 2 | 6.7 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Erythema, Post-Inj. 1 | 7.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Asthenia, Post-Inj. 2 | 7.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Swelling, Post-Inj. 1 | 6.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Myalgia, Post-Inj. 3 | 17.1 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Injection site Pain, Post- Inj. 1 | 28.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Fever, Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Erythema, Post- Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Fever, Post-Inj. 2 | 1.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Swelling, Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Headache, Post-Inj. 2 | 22.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Injection site Pain, Post- Inj. 1 | 16.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Asthenia, Post-Inj. 3 | 3.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Erythema, Post- Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Asthenia, Post-Inj. 3 | 11.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Swelling, Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Fever, Post-Inj. 3 | 2.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Injection site Pain, Post- Inj. 2 | 42.1 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Headache, Post-Inj. 2 | 24.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Erythema, Post-Inj. 2 | 5.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Headache, Post-Inj. 3 | 23.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Swelling, Post-Inj. 2 | 3.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Asthenia, Post-Inj. 3 | 11.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Injection site Pain, Post- Inj. 2 | 44.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Headache, Post-Inj. 1 | 16.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Erythema, Post- Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Malaise, Post-Inj. 2 | 20.1 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Swelling, Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Malaise, Post-Inj. 1 | 13.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Injection site Pain, Post- Inj. 2 | 62.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Headache, Post-Inj. 3 | 20.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Erythema, Post- Inj. 2 | 12.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Myalgia, Post-Inj. 1 | 16.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Swelling, Post-Inj. 2 | 4.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Myalgia, Post-Inj. 2 | 32.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Injection site Pain, Post- Inj. 3 | 34.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Asthenia, Post-Inj. 1 | 3.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Erythema, Post-Inj. 3 | 6.6 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Fever, Post-Inj. 3 | 1.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Inj. site Swelling, Post-Inj. 3 | 2.6 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Fever, Post-Inj. 1 | 2.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Injection site Pain, Post- Inj. 3 | 38.6 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Asthenia, Post-Inj. 2 | 12.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Erythema, Post- Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Malaise, Post-Inj. 1 | 17.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Inj. site Swelling, Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Malaise, Post-Inj. 3 | 18.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Injection site Pain, Post- Inj. 3 | 60.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Myalgia, Post-Inj. 1 | 23.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Erythema, Post- Inj. 3 | 13.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Fever, Post-Inj. 3 | 6.6 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Inj. site Swelling, Post-Inj. 3 | 8.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Asthenia, Post-Inj. 1 | 6.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Fever, Post-Inj. 1 | 6.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Myalgia, Post-Inj. 3 | 31.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Headache, Post-Inj. 1 | 39.1 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Headache, Post-Inj. 1 | 29.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Fever, Post-Inj. 1 | 1.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Malaise, Post-Inj. 1 | 20.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Headache, Post-Inj. 3 | 11.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Myalgia, Post-Inj. 1 | 19.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Myalgia, Post-Inj. 3 | 25.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Asthenia, Post-Inj. 1 | 7.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Malaise, Post-Inj. 2 | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Fever, Post-Inj. 2 | 6.6 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Malaise, Post-Inj. 3 | 14.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Headache, Post-Inj. 2 | 15.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 12-17 years; Myalgia, Post-Inj. 2 | 28.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 2-11 years; Malaise, Post-Inj. 2 | 13.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo | 18-45 years; Malaise, Post-Inj. 3 | 18.4 Percentage of participants |
Primary
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: Pre-Injection 1 and 28 days Post-Injection 3
Population: Analysis was performed on Per-Protocol analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=1 serotype; Pre- Inj. 1 | 19.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=2 serotypes; Post-Inj. 3 | 95.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=3 serotypes; Post-Inj. 3 | 97.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1 | 7.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1 | 6.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=3 serotypes; Post-Inj. 3 | 81.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1 | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue All 4 serotypes; Post-Inj. 3 | 61.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue All 4 serotypes; Post-Inj. 3 | 59.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue All 4 serotypes; Post-Inj. 3 | 84.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=1 serotype; Pre-Inj. 1 | 47.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=2 serotypes; Post-Inj. 3 | 99.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=1 serotype; Post-Inj. 3 | 100 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=1 serotype; Pre-Inj. 1 | 13.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1 | 33.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=1 serotype; Post-Inj. 3 | 100 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=2 serotypes; Post-Inj. 3 | 96.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=1 serotype; Post-Inj. 3 | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1 | 27.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1 | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=3 serotypes; Post-Inj. 3 | 83.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1 | 7.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1 | 22.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1 | 5.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1 | 21.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue All 4 serotypes; Post-Inj. 3 | 26.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=1 serotype; Pre- Inj. 1 | 27.7 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=1 serotype; Post-Inj. 3 | 56.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=2 serotypes; Post-Inj. 3 | 2.7 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue >=3 serotypes; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 yrs, CYD dengue All 4 serotypes; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=1 serotype; Pre-Inj. 1 | 15.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=1 serotype; Post-Inj. 3 | 26.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1 | 4.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=2 serotypes; Post-Inj. 3 | 10.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1 | 2.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue >=3 serotypes; Post-Inj. 3 | 10.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 yrs, CYD dengue All 4 serotypes; Post-Inj. 3 | 7.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=1 serotype; Pre-Inj. 1 | 53.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=1 serotype; Post-Inj. 3 | 55.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1 | 38.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=2 serotypes; Post-Inj. 3 | 35.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1 | 31.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 yrs, CYD dengue >=3 serotypes; Post-Inj. 3 | 32.4 Percentage of participants |
Primary
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: Pre-Injection 1 and 28 days Post-Injection 3
Population: Analysis was performed on Per-Protocol analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 3; Post-Inj. 3 | 98.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 2; Pre-Inj. 1 | 10.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 1; Pre-Inj. 1 | 4.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 1; Post-Inj. 3 | 92.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 2; Pre-Inj. 1 | 5.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 2; Post-Inj. 3 | 93.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 3; Pre-Inj. 1 | 11.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 4; Pre-Inj. 1 | 6.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 4; Post-Inj. 3 | 96.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 1; Pre-Inj. 1 | 5.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 1; Post-Inj. 3 | 68.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 2; Post-Inj. 3 | 87.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 3; Pre-Inj. 1 | 11.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 3; Post-Inj. 3 | 88.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 4; Pre-Inj. 1 | 6.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 4; Post-Inj. 3 | 91.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 1; Pre-Inj. 1 | 34.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 1; Post-Inj. 3 | 76.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 2; Pre-Inj. 1 | 34.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 2; Post-Inj. 3 | 81.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 3; Pre-Inj. 1 | 37.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 3; Post-Inj. 3 | 91.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 4; Pre-Inj. 1 | 26.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 4; Post-Inj. 3 | 92.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 4; Pre-Inj. 1 | 30.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 3; Pre-Inj. 1 | 10.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 2; Pre-Inj. 1 | 4.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 2; Pre-Inj. 1 | 38.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 3; Post-Inj. 3 | 21.1 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 1; Post-Inj. 3 | 10.8 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 3; Post-Inj. 3 | 41.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 2; Pre-Inj. 1 | 2.1 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 4; Pre-Inj. 1 | 2.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 2; Post-Inj. 3 | 16.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 2; Post-Inj. 3 | 35.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 3; Pre-Inj. 1 | 10.6 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 1; Pre-Inj. 1 | 8.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 3; Post-Inj. 3 | 13.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 4; Post-Inj. 3 | 10.5 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 4; Pre-Inj. 1 | 6.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 4; Post-Inj. 3 | 29.4 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 2-11 years, CYD dengue Serotype 4; Post-Inj. 3 | 18.9 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 1; Pre-Inj. 1 | 38.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 1; Pre-Inj. 1 | 4.3 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 3; Pre-Inj. 1 | 39.1 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 1; Post-Inj. 3 | 13.2 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 18-45 years, CYD dengue Serotype 1; Post-Inj. 3 | 44.1 Percentage of participants |
| Placebo Group | Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | 12-17 years, CYD dengue Serotype 2; Post-Inj. 3 | 10.5 Percentage of participants |
Secondary
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay.
Time frame: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 8.31 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 6.84 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 7.45 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 71.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 8.02 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 19.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 28.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 20.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 7.41 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 15.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 16.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 13.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 48.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 5.83 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 18.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 79.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 30.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 9.69 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 33.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 13.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 23.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 6.47 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 20.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 14.0 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 5.43 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 5.54 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 6.17 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 6.45 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 5.47 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 6.36 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 5.69 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 5.91 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 5.54 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 5.58 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 6.38 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 5.77 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 5.80 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 6.83 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 8.10 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 6.27 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 7.54 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 6.17 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 6.47 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 5.08 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 5.17 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 6.18 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 5.55 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 5.51 Titers (1/dilution) |
Secondary
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
GMTs against each serotype with the dengue virus strain were assessed using a dengue PRNT assay.
Time frame: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 26.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 24.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 16.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 66.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 66.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 32.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 70.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 46.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 23.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 50.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 38.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 14.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 88.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 45.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 64.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 48.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 28.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 10.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 122 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 52.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 32.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 15.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 48.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 26.3 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 19.2 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 13.3 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 10.0 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 21.0 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 14.8 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 15.2 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 19.3 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 15.2 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 19.9 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 15.5 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 19.4 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 16.2 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 9.87 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 8.50 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 14.7 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 8.39 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 13.9 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 7.54 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 14.4 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 11.8 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 20.0 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 16.3 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 17.0 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 11.7 Titers (1/dilution) |
Secondary
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay.
Time frame: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; Post-Injection 3 | 56.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; 2nd year follow up | 8.89 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; Pre-Injection 1 | 5.85 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; Pre-Injection 1 | 6.24 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; 3rd year follow up | 14.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; 4th year follow up | 11.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; Pre-Injection 1 | 5.33 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; 1st year follow up | 12.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; 3rd year follow up | 7.35 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; 4th year follow up | 6.21 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; Post-Injection 3 | 101 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; 1st year follow up | 21.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; 2nd year follow up | 16.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; 3rd year follow up | 11.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; 4th year follow up | 14.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; Post-Injection 3 | 136 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; 1st year follow up | 25.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; 2nd year follow up | 29.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; Pre-Injection 1 | 5.64 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; Post-Injection 3 | 104 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; 1st year follow up | 31.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; 2nd year follow up | 30.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; 3rd year follow up | 22.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; 4th year follow up | 16.5 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; 3rd year follow up | 6.31 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; 2nd year follow up | 6.11 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; Pre-Injection 1 | 5.39 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; Pre-Injection 1 | 5.17 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; 4th year follow up | 5.11 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; 3rd year follow up | 5.58 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; 2nd year follow up | 5.68 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; 3rd year follow up | 5.43 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; Pre-Injection 1 | 5.95 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; 4th year follow up | 5.09 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; Post-Injection 3 | 7.20 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; Pre-Injection 1 | 5.42 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; 1st year follow up | 5.52 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; Post-Injection 3 | 6.06 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; Post-Injection 3 | 6.54 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; 2nd year follow up | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; 4th year follow up | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; 3rd year follow up | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; 1st year follow up | 5.87 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 1; 4th year follow up | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 4; 1st year follow up | 5.69 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; Post-Injection 3 | 5.88 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 3; 2nd year follow up | 10.1 Titers (1/dilution) |
| Placebo Group | GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine | CYD dengue Serotype 2; 1st year follow up | 5.86 Titers (1/dilution) |
Secondary
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers \>=10 (1/dilution) against at least one dengue serotype at baseline.
Time frame: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 43.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 80.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 82.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 68.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 46.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 71.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 73.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 76.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 42.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 68.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 58.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 71.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 93.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 94.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 94.4 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 33.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 16.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 16.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 16.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 33.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 16.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 50.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 16.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 50.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 33.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 16.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 16.7 Percentage of participants |
Secondary
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each serotype with the dengue virus strain were assessed using a PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers \<10 (1/dilution) against all dengue serotypes at baseline.
Time frame: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 59.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 67.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 62.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 7.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 55.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 12.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 62.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 45.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 16.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 81.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 38.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 44.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 49.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 87.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 30.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 89.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 31.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 20.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 53.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 69.6 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 8.8 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 5.9 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 2.9 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 3.1 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 16.2 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 2.9 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 5.9 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 2.9 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 3.1 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 5.4 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 2.9 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 6.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 5.6 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 8.1 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 2.8 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 5.9 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 2.9 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 3.1 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 8.1 Percentage of participants |
Secondary
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 4th year follow up | 9.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 4th year follow up | 44.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; Pre- Injection 1 | 7.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; Post- Injection 3 | 80.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 1st year follow up | 33.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 2nd year follow up | 31.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 1st year follow up | 15.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; Pre-Injection 1 | 13.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; Post- Injection 3 | 97.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 1st year follow up | 94.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 2nd year follow up | 93.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 3rd year follow up | 89.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 4th year follow up | 81.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; Pre- Injection 1 | 7.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; Post- Injection 3 | 94.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 1st year follow up | 60.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 2nd year follow up | 62.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 3rd year follow up | 45.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 3rd year follow up | 22.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 4th year follow up | 20.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; Pre- Injection 1 | 5.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; Post- Injection 3 | 57.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 2nd year follow up | 11.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 3rd year follow up | 8.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 2nd year follow up | 7.5 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 4th year follow up | 8.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 4th year follow up | 5.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; Pre- Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; Pre- Injection 1 | 4.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; Post- Injection 3 | 9.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 3rd year follow up | 5.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 1st year follow up | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; Post- Injection 3 | 9.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; Post- Injection 3 | 7.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 2nd year follow up | 7.5 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 1st year follow up | 2.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 3rd year follow up | 5.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 4th year follow up | 5.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 1st year follow up | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; Pre-Injection 1 | 15.2 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 4th year follow up | 5.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; Post- Injection 3 | 25.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 2nd year follow up | 10.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 1st year follow up | 7.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 3rd year follow up | 5.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 2nd year follow up | 15.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; Pre- Injection 1 | 2.2 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 3rd year follow up | 5.0 Percentage of participants |
Secondary
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers \>=10 (1/dilution).
Time frame: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 52.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 19.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 35.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 25.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 36.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 6.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 11.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 16.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 88.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 83.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 61.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 11.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 56.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 48.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 9.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 91.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 5.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 73.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 71.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 47.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 66.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 44.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 61.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 67.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 8.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 5.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 2.2 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 2.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 4.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 11.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 7.5 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 5.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 5.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 4.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 9.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 10.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 5.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 5.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 10.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 20.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 5.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 12.5 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 5.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 9.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 10.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 5.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 7.3 Percentage of participants |
Secondary
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers \>=10 (1/dilution) against at least one dengue serotype at baseline.
Time frame: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 88.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 77.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 84.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 91.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 92.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 88.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 91.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 98.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 90.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 98.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 94.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 91.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 98.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 96.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 86.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 80.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 89.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 63.2 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 70.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 73.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 42.1 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 66.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 61.1 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 65.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 71.4 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 65.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 70.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 65.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 68.4 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 44.4 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 66.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 47.6 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 60.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 57.1 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 66.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 45.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 70.0 Percentage of participants |
Secondary
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers \<10 (1/dilution) against all dengue serotypes at baseline.
Time frame: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 21.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 10.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 7.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 5.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 73.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 49.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 50.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 28.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 26.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 87.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 48.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 61.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 46.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 28.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 87.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 78.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 71.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 66.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 63.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 59.4 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 9.5 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 14.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 5.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 14.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 21.1 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 14.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 14.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 5.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 5.6 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 4.8 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 14.3 Percentage of participants |
Secondary
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; Post- Injection 3 | 97.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 2nd year follow up | 76.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; Pre-Injection 1 | 46.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 3rd year follow up | 63.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 1st year follow up | 73.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; Post- Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; Post- Injection 3 | 83.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; Pre- Injection 1 | 26.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 1st year follow up | 55.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 1st year follow up | 96.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 2nd year follow up | 56.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 3rd year follow up | 93.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 3rd year follow up | 46.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 2nd year follow up | 96.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 4th year follow up | 43.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 1st year follow up | 41.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; Pre- Injection 1 | 21.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 4th year follow up | 92.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; Post- Injection 3 | 56.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 3rd year follow up | 39.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 2nd year follow up | 41.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; Pre- Injection 1 | 32.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 4th year follow up | 37.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 4th year follow up | 54.2 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 4th year follow up | 21.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; Post- Injection 3 | 32.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 1st year follow up | 38.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 4th year follow up | 28.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; Post- Injection 3 | 23.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 3rd year follow up | 17.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; Pre-Injection 1 | 55.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; Post- Injection 3 | 53.5 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 1st year follow up | 50.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 3rd year follow up | 41.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 4th year follow up | 36.8 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; Pre- Injection 1 | 38.8 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 2nd year follow up | 34.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 Serotypes; 3rd year follow up | 33.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; Pre- Injection 1 | 32.7 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; Post- Injection 3 | 27.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 1st year follow up | 34.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 2nd year follow up | 29.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 Serotypes; 3rd year follow up | 30.8 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 4th year follow up | 26.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; Pre- Injection 1 | 22.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 1st year follow up | 18.2 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 Serotypes; 2nd year follow up | 19.5 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 Serotype; 2nd year follow up | 56.1 Percentage of participants |
Secondary
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 71.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 43.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 40.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 39.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 32.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 80.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 66.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 68.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 55.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 55.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 36.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 92.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 68.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 77.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 67.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 56.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 25.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 33.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 45.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 93.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 86.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 81.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 79.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 77.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 38.8 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 31.8 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 30.8 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 29.7 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 24.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 34.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 34.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 39.5 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 38.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 31.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 29.5 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 38.8 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 46.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 30.2 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 31.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 40.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 35.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 34.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 20.5 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 35.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 32.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 31.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 21.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 41.7 Percentage of participants |
Secondary
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers \>=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers \>=10 (1/dilution) against at least one dengue serotype at baseline.
Time frame: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 33.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 70.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 70.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 96.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 88.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 74.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 81.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 22.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 48.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 48.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 85.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 88.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 66.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 59.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 74.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 50.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 55.6 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 15.4 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 16.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 7.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 23.1 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 15.4 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 16.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 7.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 15.4 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 16.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 23.1 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 16.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 8.3 Percentage of participants |
Secondary
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers \<10 (1/dilution) against all dengue serotypes at baseline.
Time frame: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 89.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 33.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 20.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 12.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 6.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 93.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 49.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 34.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 97.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 60.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 72.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 47.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 34.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 96.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 73.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 58.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 44.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 54.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 31.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow | 71.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 3.2 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 12.5 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 6.5 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 3.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 9.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 19.4 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 12.5 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 6.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 3.2 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 6.5 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 3.3 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 9.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 9.7 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 3.2 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 34.5 Percentage of participants |
| Placebo Group | Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 0.0 Percentage of participants |
Secondary
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 2nd year follow up | 70.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 1st year follow up | 66.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; Pre- Injection 1 | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; Pre-Injection 1 | 19.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 3rd year follow up | 48.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; Pre-Injection 1 | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 4th year follow up | 35.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 1st year follow up | 92.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 3rd year follow up | 76.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 2nd year follow up | 42.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 3rd year follow up | 23.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; Post- Injection 3 | 96.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 4th year follow up | 16.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 4th year follow up | 72.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; Post- Injection 3 | 84.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 1st year follow up | 52.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 1st year follow up | 29.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; Pre-Injection 1 | 6.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 2nd year follow up | 15.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 2nd year follow up | 95.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 3rd year follow up | 11.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; Post- Injection 3 | 99.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 4th year follow up | 6.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; Post-Injection 3 | 100.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 4th year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 1st year follow up | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 2nd year follow up | 34.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 1st year follow up | 6.7 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 2nd year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 4th year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; Pre-Injection 1 | 26.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; Post-Injection 3 | 51.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 3rd year follow up | 7.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=1 serotype; 4th year follow up | 4.8 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; Post- Injection 3 | 4.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 2nd year follow up | 9.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 3rd year follow up | 7.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=2 serotypes; 4th year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; Post- Injection 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 1st year follow up | 2.2 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue >=3 serotypes; 3rd year follow up | 4.7 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; Pre- Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; Post- Injection 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 1st year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 2nd year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue All 4 serotypes; 3rd year follow up | 0.0 Percentage of participants |
Secondary
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Time frame: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Population: Full analysis set included participants who received at least 1 dose of CYD dengue vaccine or Placebo, had at least 1 blood sample drawn and valid post-vaccination serology result. Here, 'overall number of participants analyzed'=participants evaluable for 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 Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 66.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 59.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 41.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 52.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 97.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 34.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 27.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 74.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 6.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 50.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 16.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 37.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 4.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 9.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 97.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 11.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 75.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 5.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 72.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 91.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 60.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 94.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 49.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 36.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 4th year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 4th year follow up | 2.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Pre-Injection 1 | 10.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; Post-Injection 3 | 13.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 1st year follow up | 9.1 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Pre-Injection 1 | 8.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; Post-Injection 3 | 8.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 1st year follow up | 6.8 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 2nd year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 3rd year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 1; 4th year follow up | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Pre-Injection 1 | 2.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; Post-Injection 3 | 13.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 1st year follow up | 8.9 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 2nd year follow up | 11.6 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 2; 3rd year follow up | 7.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 2nd year follow up | 29.3 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 3rd year follow up | 4.7 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 3; 4th year follow up | 2.4 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Pre-Injection 1 | 6.0 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; Post-Injection 3 | 20.5 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 1st year follow up | 4.7 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 2nd year follow up | 4.7 Percentage of participants |
| Placebo Group | Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo | CYD dengue Serotype 4; 3rd year follow up | 7.0 Percentage of participants |