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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01411241 | Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers | PHASE3 | COMPLETED | 720 | — | — | Jul 18, 2011 | Apr 1, 2014 | Mar 25, 2022 | 4 | Mexico |
Antibodies (Ab) against diphtheria, tetanus toxoid, pertussis toxoid (PT), and filamentous hemaglutinin (FHA) was measured by enzyme-linked immunosorbent assay (ELISA), polyribosylribitol phosphate (PRP) by Farr-type radioimmunoassay, and poliovirus types 1, 2, and 3 by seroneutralization assay. Seroprotection was defined as \>=0.1 International Unit (IU)/mL for diphtheria toxoid and tetanus toxoid, \>=8 1/dil for poliovirus types 1, 2, and 3, and \>=1.0 μg/mL for PRP. Booster response to PT and FHA: participants whose pre-vaccination Ab titers were \< lower limit of quantitation (LLOQ), a booster response occurred if they had post-vaccination levels \>=4\* LLOQ; participants whose pre-vaccination Ab concentrations were \>=LLOQ but \<4\* LLOQ, a booster response occurred if they had a 4-fold increase (post/pre-vaccination levels \>=4); for participants whose pre-vaccination Ab concentrations were \>=4\* LLOQ, a booster response occurred if they had a 2-fold increase (post/pre-vaccination \>=2).
| Arm | Type | Description |
|---|---|---|
| CYD Dengue Vaccine Group 1 | EXPERIMENTAL | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a measles, mumps, rubella (MMR) vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), a booster dose of Pentaxim vaccine was administered concomitantly with the second injection of CYD dengue vaccine at Month 6 (15 to 18 months of age), placebo at Month 7 (16 to 19 months of age) to maintain the blind, and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
| CYD Dengue Vaccine Group 2 | EXPERIMENTAL | Participants received the first injection of CYD dengue vaccine at Month 0 (9 to 12 months of age), a MMR vaccine and pneumococcal conjugate vaccine at Month 1 (10 to 13 months of age), the Pentaxim vaccine was administered concomitantly with placebo at Month 6 (15 to 18 months of age) to maintain the blind, a second injection of CYD dengue vaccine at Month 7 (16 to 19 months of age), and the third injection of CYD dengue vaccine at Month 12 (21 to 24 months). |
| Name | Type | Description |
|---|---|---|
| Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus | BIOLOGICAL | 0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months. |
| DTaP IPV//Hib vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
| Placebo | BIOLOGICAL | 0.5 mL, subcutaneous |
| Measles, mumps, and rubella vaccine | BIOLOGICAL | 0.5 mL, subcutaneous |
| Pneumococcal vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
Inclusion Criteria: * Aged 9 to 12 months on the day of inclusion. * Born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 2.5 kg. * Participant in good health, based on medical history and physical examination. * Documentation of completion of the primary vaccination series wit...
| 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 |