Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00875524 | Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects | PHASE2 | COMPLETED | 180 | — | — | Mar 1, 2009 | Dec 1, 2014 | Apr 5, 2022 | 1 | Vietnam |
| NCT00788151 | Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years | PHASE2 | COMPLETED | 300 | — | — | Sep 26, 2008 | Aug 16, 2010 | Apr 5, 2022 | 1 | Peru |
Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).
GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain:- Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema and Swelling:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>= 5 cm.
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: \>=37.5 degree Celsius (°C) to \<=38.0°C, Grade 2: \>38.0°C to \<=39.0°C, Grade 3: \>39.0°C. Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
| Arm | Type | Description |
|---|---|---|
| CYD Dengue Vaccine Group | EXPERIMENTAL | Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection. |
| Control Vaccine Group | SHAM_COMPARATOR | Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection. |
| Control group | PLACEBO_COMPARATOR | Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). |
| Name | Type | Description |
|---|---|---|
| CYD dengue vaccine serotypes (1, 2, 3, 4). | BIOLOGICAL | 0.5 mL, Subcutaneous |
| Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide | BIOLOGICAL | Each at 0.5 mL, Subcutaneous, respectively |
| CYD Dengue Vaccine Serotypes 1, 2, 3, and 4 | BIOLOGICAL | 0.5 mL, Subcutaneous (SC) |
| Pneumococcal polysaccharide vaccine | BIOLOGICAL | 0.5 mL, SC |
Inclusion Criteria : * Aged 2 to 45 years on the day of inclusion. * Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants \<18 years). * Participant (and parent/guardian for participants \<18 years) a...