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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01436396 | Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers | PHASE3 | COMPLETED | 792 | — | — | Sep 7, 2011 | Sep 2, 2013 | Mar 25, 2022 | 2 | Colombia, Peru |
| NCT01488890 | Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine | PHASE2 | COMPLETED | 390 | — | — | Dec 6, 2011 | Sep 27, 2013 | Mar 24, 2022 | 7 | United States |
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>=10 (1/dilution \[dil\]) in flavivirus non-immune participants (defined as those with YF antibodies \<10 \[1/dil\] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus).
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer \>=10 (1/dilution).
| Arm | Type | Description |
|---|---|---|
| CYD Dengue Vaccine Group | EXPERIMENTAL | Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (Month \[M\] 0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP-IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
| Placebo Group | EXPERIMENTAL | Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). |
| CYD Dengue vaccine: Group 1 | EXPERIMENTAL | Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. |
| CYD Dengue vaccine: Group 2 | EXPERIMENTAL | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. |
| CYD Dengue and Yellow Fever vaccine: Group 3 | EXPERIMENTAL | Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. |
| Yellow Fever vaccine: Group 4 | ACTIVE_COMPARATOR | Participants received single dose of YF vaccine at Day 0. |
| Name | Type | Description |
|---|---|---|
| Live, attenuated dengue serotype 1, 2, 3, and 4 virus | BIOLOGICAL | 0.5 mL, subcutaneous at age 12, 18, and 24 months |
| Yellow fever vaccine | BIOLOGICAL | 0.5 mL subcutaneous in the deltoid at age 12 to 13 months. |
| Measles, mumps, and rubella (MMR) vaccine | BIOLOGICAL | 0.5 mL, subcutaneous at age 12 to 13 months. |
| Pneumococcal Conjugated Vaccine | BIOLOGICAL | 0.5 mL, intramuscular at age 13 to 14 months |
| Hepatitis A Pediatric Vaccine | BIOLOGICAL | 0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months |
| Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine | BIOLOGICAL | 0.5 mL, intramuscular at age 19 to 20 months |
| Placebo (NaCl) | BIOLOGICAL | 0.5 mL, subcutaneous at age 12 to 13 months |
| Measles, mumps, and rubella vaccine | BIOLOGICAL | 0.5 mL, subcutaneous at age 13 to 14 months |
| Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus | BIOLOGICAL | 0.5 mL, Subcutaneous |
| Yellow Fever | BIOLOGICAL | 0.5 mL, Subcutaneous |
Inclusion Criteria: * Aged 12 to 13 months on the day of inclusion. * Born at full term of pregnancy (\>=37 weeks) and with a birth weight \>=2.5 kg as reported by the parent/legally acceptable representative. * Participant in good health, based on medical history and physical examination. * Partic...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 5 | PHASE3 | Tetravalent Dengue Vaccine, TDV |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | EYU688 |
| Sanofi SA Sponsored ADR | SNY | 1 | — | Undisclosed |
| Abbott Laboratories | ABT | 1 | — | Undisclosed |
| Danaher Corporation | DHR | 1 | — | Undisclosed |