Dengue Fever, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue fever, Dengue hemorrhagic fever, CYD dengue vaccine
Brief summary
The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia. Primary Objectives: * To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD dengue vaccine in all participants after each injection. * To describe the antibody response to each dengue virus serotype post-injection 2 and post-injection 3.
Detailed description
Healthy participants aged 2 to 11 years received 3 vaccinations at pre-determined schedules and were followed-up for at least 6 months after the last vaccination.
Interventions
0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension
BIOLOGICALPlacebo: NaCl 0.9%
0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 2 to 11 years on the day of inclusion * Assent form was signed and dated by the participant (for participants ≥ 7 years) and informed consent form was signed and dated by the parent(s) or another legally accepted representative, and by an independent witness if the two parents or legally accepted representative were illiterate * Participant and parent/legally accepted representative were able to attend all scheduled visits to comply with all trial procedures * Participants in good health, based on medical history and physical examination * For a female participant of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination
Exclusion criteria
* Known pregnancy, or a positive urine pregnancy test (for female participant of child-bearing potential only) * Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Planned receipt of any vaccine in the 4 weeks following the trial first vaccination, except for pandemic influenza vaccination * Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Seropositivity for human immunodeficiency virus (HIV) reported by the parent/legally acceptable representative * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances * Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion * Participants who plan to move to another country/region within the 18 coming months * Identified as a child (adopted or natural) of the Investigator or of site employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Day 0 up to Day 14 post-any and each vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain: Incapacitating, unable to perform usual activities; Erythema and Swelling: \>=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: \>=39°Degree Celsius (C); Headache, Malaise, Myalgia, and Asthenia: Significant: Prevents daily activity. |
| Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Day 0 up to Day 14 post-each vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype with parental dengue virus strains (serotype 1, 2, 3, and 4) in the baseline sample. |
| Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Day 0 up to Day 14 post-each vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. |
| Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and Post-Injections 2 and 3 | Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each dengue serotype (1,2, 3 and 4) and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). |
| Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and Post-Injections 2 and 3 | Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each dengue serotype (1, 2, 3, and 4) and was assessed using the dengue PRNT. |
| Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and Post-Injections 2 and 3 | GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the dengue PRNT. |
| Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Pre-Injection 1 and Post-Injections 2 and 3 | Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. |
| Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Pre-Injection 1 and Post-Injections 2 and 3 | Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus naïve participants were defined as participants without quantified antibodies against Japanese encephalitis and without quantified antibodies against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. |
| GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and Post-Injections 2 and 3 | GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. |
| GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and Post- Injections 2 and 3 | GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample. |
Countries
Malaysia
Participant flow
Recruitment details
Study participants were enrolled from 02 December 2010 to 10 February 2011 at 4 clinical sites in Malaysia.
Pre-assignment details
A total of 250 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 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | 199 |
| Placebo Group Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. | 51 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Serious adverse event | 0 | 1 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine Group | Placebo Group | Total |
|---|---|---|---|
| Age, Customized 2 to 5 years | 99 Years | 26 Years | 125 Years |
| Age, Customized 6 to 11 years | 100 Years | 25 Years | 125 Years |
| Sex: Female, Male Female | 103 Participants | 19 Participants | 122 Participants |
| Sex: Female, Male Male | 96 Participants | 32 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 199 | 0 / 51 |
| other Total, other adverse events | 138 / 199 | 29 / 51 |
| serious Total, serious adverse events | 11 / 199 | 7 / 51 |
Outcome results
Primary
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the dengue PRNT.
Time frame: Pre-Injection 1 and Post-Injections 2 and 3
Population: Analysis was performed on Full 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) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 15.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 119 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 151 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 15.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 160 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 180 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 15.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 196 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 193 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 9.92 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 110 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 114 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 13.3 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 18.6 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 15.9 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 21.0 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 12.3 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 18.9 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 15.9 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 18.6 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 10.9 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 17.9 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 16.3 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 16.3 Titers (1/dilution) |
Primary
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Time frame: Pre-Injection 1 and Post- Injections 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 47.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 81.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 71.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 97.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 116 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 117 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 73.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 78.0 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 5.95 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 5.98 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 7.38 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 5.00 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 5.54 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 5.00 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 6.17 Titers (1/dilution) |
| Placebo Group | GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 6.03 Titers (1/dilution) |
Primary
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Time frame: Pre-Injection 1 and Post-Injections 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies 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 Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 37.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 248 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 247 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 39.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 306 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 292 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 38.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 296 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 287 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 17.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 152 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 155 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 21.7 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 41.7 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 33.2 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 45.4 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 21.3 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 33.5 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 32.4 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 41.6 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 16.5 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 39.0 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 29.5 Titers (1/dilution) |
| Placebo Group | GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 30.0 Titers (1/dilution) |
Primary
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype with parental dengue virus strains (serotype 1, 2, 3, and 4) in the baseline sample.
Time frame: Day 0 up to Day 14 post-each vaccination
Population: Analysis was performed on safety analysis set. Here, overall number of participants analyzed signifies 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 Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Malaise; Post-Injection 2 | 29.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Myalgia; Post-Injection 2 | 19.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Headache; Post-Injection 2 | 31.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Pain; Post-Injection 3 | 34.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Erythema; Post-Injection 3 | 21.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Swelling; Post-Injection 3 | 15.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Asthenia; Post-Injection 3 | 13.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Fever; Post-Injection 3 | 10.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Malaise; Post-Injection 3 | 18.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Myalgia; Post-Injection 3 | 14.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Headache; Post-Injection 3 | 19.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Pain; Post-Injection 1 | 44.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Erythema; Post-Injection 1 | 14.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Swelling; Post-Injection 1 | 13.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Asthenia; Post-Injection 1 | 27.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Fever; Post-Injection 1 | 12.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Malaise; Post-Injection 1 | 38.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Myalgia; Post-Injection 1 | 22.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Headache; Post-Injection 1 | 36.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Pain; Post-Injection 2 | 48.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Swelling; Post-Injection 2 | 9.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Asthenia; Post-Injection 2 | 21.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Fever; Post-Injection 2 | 18.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Erythema; Post-Injection 2 | 25.5 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Swelling; Post-Injection 2 | 16.1 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Malaise; Post-Injection 2 | 3.2 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Erythema; Post-Injection 1 | 29.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Myalgia; Post-Injection 2 | 12.9 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Headache; Post-Injection 1 | 29.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Headache; Post-Injection 2 | 12.9 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Swelling; Post-Injection 1 | 22.6 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Pain; Post-Injection 3 | 41.9 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Fever; Post-Injection 2 | 9.7 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Erythema; Post-Injection 3 | 22.6 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Asthenia; Post-Injection 1 | 25.8 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Swelling; Post-Injection 3 | 22.6 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Pain; Post-Injection 2 | 32.3 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Asthenia; Post-Injection 3 | 16.1 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Fever; Post-Injection 1 | 13.3 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Fever; Post-Injection 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Erythema; Post-Injection 2 | 29.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Malaise; Post-Injection 3 | 16.1 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Malaise; Post-Injection 1 | 38.7 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Myalgia; Post-Injection 3 | 16.1 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Asthenia; Post-Injection 2 | 9.7 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Headache; Post-Injection 3 | 19.4 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Myalgia; Post-Injection 1 | 25.8 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine | Injection site Pain; Post-Injection 1 | 29.0 Percentage of participants |
Primary
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Time frame: Day 0 up to Day 14 post-each vaccination
Population: Analysis was performed on safety analysis set. Here, ''overall number of participants analyzed signifies 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 Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling; Post-Injection 2 | 23.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Fever; Post-Injection 3 | 8.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Asthenia; Post-Injection 2 | 26.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Fever; Post-Injection 2 | 11.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Malaise; Post-Injection 1 | 34.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Malaise; Post-Injection 2 | 26.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling; Post-Injection 1 | 25.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Myalgia; Post-Injection 2 | 18.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Myalgia; Post-Injection 1 | 22.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Headache; Post-Injection 2 | 29.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Pain; Post-Injection 3 | 47.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Pain; Post-Injection 2 | 48.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema; Post-Injection 3 | 26.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Headache; Post-Injection 1 | 37.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling; Post-Injection 3 | 25.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Asthenia; Post-Injection 1 | 28.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Asthenia; Post-Injection 3 | 25.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema; Post-Injection 1 | 31.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Malaise; Post-Injection 3 | 23.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema; Post-Injection 2 | 42.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Myalgia; Post-Injection 3 | 20.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Fever; Post-Injection 1 | 12.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Headache; Post-Injection 3 | 26.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Pain; Post-Injection 1 | 37.5 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Headache; Post-Injection 3 | 5.3 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Asthenia; Post-Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Headache; Post-Injection 2 | 21.1 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Asthenia; Post-Injection 3 | 5.3 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Pain; Post-Injection 1 | 25.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema; Post-Injection 1 | 15.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling; Post-Injection 1 | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Asthenia; Post-Injection 1 | 10.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Fever; Post-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Malaise; Post-Injection 1 | 15.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Myalgia; Post-Injection 1 | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Headache; Post-Injection 1 | 25.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Pain; Post-Injection 2 | 15.8 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema; Post-Injection 2 | 36.8 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling; Post-Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Fever; Post-Injection 2 | 11.1 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Malaise; Post-Injection 2 | 10.5 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Myalgia; Post-Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Pain; Post-Injection 3 | 31.6 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Erythema; Post-Injection 3 | 26.3 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Injection site Swelling; Post-Injection 3 | 26.3 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Fever; Post-Injection 3 | 5.3 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Malaise; Post-Injection 3 | 5.3 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine | Myalgia; Post-Injection 3 | 0.0 Percentage of participants |
Primary
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain: Incapacitating, unable to perform usual activities; Erythema and Swelling: \>=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: \>=39°Degree Celsius (C); Headache, Malaise, Myalgia, and Asthenia: Significant: Prevents daily activity.
Time frame: Day 0 up to Day 14 post-any and each vaccination
Population: Analysis was performed on safety analysis set which included participants who received any dose of CYD dengue vaccine or placebo and were analyzed according to the treatment received at this injection. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Any Inj. | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Any Inj. | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Inj. 2 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Any Inj. | 54.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Inj. 2 | 18.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Any Inj. | 3.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 2 | 33.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Any Inj. | 37.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 1 | 41.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Any Inj. | 2.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Inj. 1 | 28.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Inj. 1 | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Any Inj. | 46.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Inj. 1 | 12.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 2 | 15.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Inj. 1 | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Inj. 1 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Inj. 1 | 37.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Inj. 1 | 1.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Inj. 3 | 3.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Inj. 1 | 36.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 3 | 40.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Inj. 1 | 2.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Inj. 3 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Inj. 1 | 22.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 1 | 22.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Inj. 1 | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 3 | 23.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Inj. 2 | 23.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Any Inj. | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Inj. 2 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Inj. 2 | 15.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Inj. 1 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Inj. 2 | 2.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 3 | 20.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Inj. 2 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Any Inj. | 69.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Inj. 2 | 27.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 3 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Inj. 2 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 1 | 18.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Any Inj. | 47.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Inj. 2 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Any Inj. | 38.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Inj. 3 | 19.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Any Inj. | 3.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Inj. 3 | 1.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Inj. 3 | 9.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Inj. 3 | 22.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Any Inj. | 29.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Inj. 3 | 1.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Inj. 2 | 31.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Inj. 3 | 20.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Any Inj. | 6.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Inj. 3 | 1.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 2 | 48.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Inj. 3 | 17.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Any Inj. | 52.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Inj. 3 | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Any Inj. | 1.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 3 | 38.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Inj. 1 | 19.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Inj. 2 | 16.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Inj. 3 | 2.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Any Inj. | 56.9 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Any Inj. | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Any Inj. | 49.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Any Inj. | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Any Inj. | 35.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Any Inj. | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 1 | 27.5 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 1 | 23.5 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 1 | 21.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 2 | 26.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 2 | 32.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 2 | 10.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 3 | 24.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 3 | 24.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Any Inj. | 33.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Any Inj. | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Any Inj. | 19.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Any Inj. | 3.9 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Any Inj. | 39.2 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Any Inj. | 2.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Any Inj. | 41.2 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Any Inj. | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Any Inj. | 31.4 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Any Inj. | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Inj. 1 | 8.2 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Inj. 1 | 4.1 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Inj. 1 | 27.5 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Inj. 1 | 29.4 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Inj. 1 | 23.5 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Inj. 2 | 6.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Inj. 2 | 10.2 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Inj. 2 | 2.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Inj. 2 | 6.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Inj. 2 | 8.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Inj. 3 | 12.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Inj. 3 | 14.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Inj. 3 | 12.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Inj. 3 | 10.0 Percentage of participants |
Primary
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each dengue serotype (1, 2, 3, and 4) and was assessed using the dengue PRNT.
Time frame: Pre-Injection 1 and Post-Injections 2 and 3
Population: Analysis was performed on Full analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 1 | 44.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 1 | 29.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 2 | 99.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 1 | 25.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 2 | 96.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 3 | 98.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 1 | 19.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 2 | 80.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 3 | 91.8 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 2 | 24.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 1 | 48.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 1 | 28.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 2 | 46.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 1 | 24.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 3 | 42.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 2 | 28.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 1 | 28.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 3 | 22.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 2 | 34.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 3 | 30.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 3 | 32.0 Percentage of participants |
Primary
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each dengue serotype (1,2, 3 and 4) and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Time frame: Pre-Injection 1 and Post-Injections 2 and 3
Population: Analysis was performed on Full analysis set which included participants who received at least one injection of CYD dengue vaccine or placebo and had at least one valid post-injection serology result. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 31.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 90.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 96.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 27.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 94.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 96.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 36.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 98.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 99.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 24.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 91.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 98.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 32.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 32.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 36.7 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 34.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 30.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 30.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 32.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 30.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 28.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 34.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 34.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 34.0 Percentage of participants |
Primary
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Time frame: Pre-Injection 1 and Post-Injections 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies 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 With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 3; Pre-Injection 1 | 66.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 1; Post-Injection 2 | 96.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 3; Post-Injection 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 2; Pre-Injection 1 | 49.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 3; Post-Injection 3 | 99.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 2; Post-Injection 2 | 96.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 4; Pre-Injection 1 | 43.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 1; Pre-Injection 1 | 56.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 4; Post-Injection 2 | 97.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 2; Post-Injection 3 | 97.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 4; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 1; Post-Injection 3 | 97.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 4; Post-Injection 3 | 41.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 1; Pre-Injection 1 | 51.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 1; Post-Injection 2 | 48.4 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 1; Post-Injection 3 | 41.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 2; Post-Injection 2 | 54.8 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 2; Post-Injection 3 | 48.4 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 3; Pre-Injection 1 | 60.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 3; Post-Injection 2 | 51.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 3; Post-Injection 3 | 48.4 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 4; Pre-Injection 1 | 48.4 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 4; Post-Injection 2 | 45.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants | Serotype 2; Pre-Injection 1 | 48.4 Percentage of participants |
Primary
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus naïve participants were defined as participants without quantified antibodies against Japanese encephalitis and without quantified antibodies against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Time frame: Pre-Injection 1 and Post-Injections 2 and 3
Population: Analysis was performed on Full analysis set. Here, overall number of participants analyzed signifies 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 With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 1; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 1; Post-Injection 2 | 82.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 1; Post-Injection 3 | 95.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 2; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 2; Post-Injection 2 | 93.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 2; Post-Injection 3 | 96.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 3; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 3; Post-Injection 2 | 96.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 3; Post-Injection 3 | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 4; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 4; Post-Injection 2 | 85.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 4; Post-Injection 3 | 95.4 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 4; Post-Injection 2 | 10.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 1; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 3; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 1; Post-Injection 2 | 10.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 4; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 1; Post-Injection 3 | 10.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 3; Post-Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 2; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 4; Post-Injection 3 | 5.3 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 2; Post-Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 3; Post-Injection 3 | 10.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants | Serotype 2; Post-Injection 3 | 10.5 Percentage of participants |