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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01446926 | Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants | PHASE1 | COMPLETED | 280 | — | — | Sep 1, 2011 | Jun 1, 2013 | Jan 10, 2018 | 1 | Bangladesh |
Solicited injection site reactions: For adults: Pain, Erythema, and Swelling; Toddlers and infants: Tenderness, Erythema, Swelling. Solicited systemic reactions: For adults, Fever (Temperature), Headache, Malaise, and Myalgia; Toddlers and infants, Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.
| Arm | Type | Description |
|---|---|---|
| Group 1: Adults High Dose (Formulation 1) | EXPERIMENTAL | Adults who will receive a single injection of high dose investigational Pneumococcal vaccine |
| Group 2: Adults Placebo | PLACEBO_COMPARATOR | Adult participants who will receive an injection of placebo |
| Group 3: Toddlers High Dose (Formulation 1) | EXPERIMENTAL | Toddlers who will receive a single injection of high dose Pneumococcal vaccine |
| Group 4: Toddlers Placebo | PLACEBO_COMPARATOR | Toddlers who will receive a single injection of placebo |
| Group 5: Infants Low Dose (Formulation 2) | EXPERIMENTAL | Infants who will receive 3 injections of low dose low dose Pneumococcal vaccine |
| Group 6: Infants Placebo | PLACEBO_COMPARATOR | Infants who will receive 3 injections of placebo |
| Group 7: Infants Middle Dose (Formulation 3) | EXPERIMENTAL | Infants who will receive 3 injections of middle dose Pneumococcal vaccine |
| Group 8: Infants Middle Dose (Formulation 4) | EXPERIMENTAL | Infants who will receive 3 injections of middle dose Pneumococcal vaccine |
| Group 9: Infants Placebo | PLACEBO_COMPARATOR | Infants who will receive 3 injections of placebo |
| Group 10: Infants High Dose (Formulation 1) | EXPERIMENTAL | Infants who will receive 3 injections of high dose Pneumococcal vaccine |
| Group 11: Infants Placebo | PLACEBO_COMPARATOR | Infants who will receive 3 injections of placebo |
| Name | Type | Description |
|---|---|---|
| Pneumococcal Vaccine High Dose (Formulation 1) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tris buffered saline (Placebo) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Pneumococcal Vaccine Low Dose (Formulation 2) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Pneumococcal Vaccine Middle Dose (Formulation 3) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Pneumococcal Vaccine Middle Dose (Formulation 4) | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: Adults: * Aged 18 to 50 years on the day of inclusion. * Informed consent form has been signed and dated. If the subject is unable to read the informed consent form, a site-defined standard procedure will be followed to ensure subject understanding of the process and will be ma...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tozorakimab |
| GSK plc Sponsored ADR | GSK | 3 | PHASE1 | Pn-MAPS30plus, PCV20 |
| Pfizer Inc. | PFE | 4 | — | Receipt of PCV20 |
| Sanofi SA Sponsored ADR | SNY | 1 | — | Undisclosed |
| Gilead Sciences, Inc. | GILD | 1 | — | Undisclosed |
| Grace Therapeutics, Inc. | GRCE | 1 | NA | Undisclosed |
| Co-Diagnostics, Inc. | CODX | 1 | — | Undisclosed |