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...
CYD dengue vaccine serotypes is an investigational tetravalent vaccine being developed for the prevention of dengue virus infection, including dengue fever and dengue hemorrhagic fever. It is designed to protect against the four serotypes of the dengue virus. The vaccine is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
CYD dengue vaccine serotypes is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this tetravalent dengue vaccine candidate in pediatric and adult populations.
CYD dengue vaccine serotypes is currently in Phase 2 clinical development. It is an investigational vaccine and has not yet received regulatory approval. Two Phase 2 clinical trials have been completed, involving a total of 480 participants, to assess the vaccine's safety and immunogenicity in healthy individuals.
CYD dengue vaccine serotypes has completed two Phase 2 clinical trials. The first, NCT00788151, enrolled 300 healthy children aged 2 to 11 years in Peru. The second, NCT00875524, enrolled 180 healthy subjects in Vietnam. Both trials were randomized, double-blind, and sham-controlled, and have been completed.
Yes, CYD dengue vaccine serotypes is also known as ChimeriVax tetravalent dengue vaccine. The clinical trials for this vaccine are titled 'Study of ChimeriVax™ Tetravalent Dengue Vaccine,' indicating that the product is referred to by this alternative name in research settings.