Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CYD dengue vaccine serotypes · 2 trials · 5 indications
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...
The CYD dengue vaccine serotypes is a tetravalent vaccine designed to protect against all four dengue virus serotypes, 1, 2, 3, and 4. It is being developed by Sanofi for the prevention of dengue virus infection and dengue disease, including dengue fever and dengue hemorrhagic fever.
The CYD dengue vaccine serotypes is used for the prevention of dengue virus infection. Its clinical program covers dengue fever, dengue hemorrhagic fever, and dengue disease caused by any of the four dengue serotypes. The studies enrolled healthy volunteers, including children, in Vietnam and Peru.
The CYD dengue vaccine serotypes is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating this tetravalent dengue vaccine candidate.
The CYD dengue vaccine serotypes is in Phase 2 development. Both of its recorded clinical trials are Phase 2 studies, and both have been completed. The vaccine is investigational and is not described as approved.
Two completed Phase 2 trials have evaluated the CYD dengue vaccine serotypes. NCT00875524 studied the ChimeriVax tetravalent dengue vaccine in 180 healthy subjects in Vietnam. NCT00788151 studied it in 300 healthy Peruvian children aged 2 to 11 years. Together the trials enrolled 480 participants.
Yes. The CYD dengue vaccine serotypes is also known as the CYD Dengue Vaccine Serotypes 1, 2, 3, and 4, and it has been studied under the name ChimeriVax tetravalent dengue vaccine. These names refer to the same Sanofi vaccine candidate against all four dengue serotypes.