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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05297578 | Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults | PHASE2 | COMPLETED | 207 | — | — | Jun 15, 2022 | Feb 15, 2023 | Oct 9, 2024 | 20 | United States |
| NCT05266456 | Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults | PHASE1 | COMPLETED | 835 | — | — | Feb 22, 2022 | Jan 10, 2023 | Apr 18, 2024 | 13 | United States |
Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site
Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain within 7 days of vaccination
Percentage of participants with at least one Treatment Emergent Adverse Event (unsolicited AEs and SAEs)
Percentage of participants with serious adverse events (SAEs) and new onset of chronic illness (NOCIs)
Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group
Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain
Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.
Percentage of participants with SAEs and NOCIs
| Arm | Type | Description |
|---|---|---|
| VAX-24 Low Dose | EXPERIMENTAL | Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1. |
| VAX-24 Mid Dose | EXPERIMENTAL | Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1. |
| VAX-24 Mixed Dose | EXPERIMENTAL | Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1. |
| PCV20 | ACTIVE_COMPARATOR | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. |
| Name | Type | Description |
|---|---|---|
| 24-Valent Pneumococcal Conjugate Vaccine | BIOLOGICAL | 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| Pneumococcal 20-valent Conjugate Vaccine | BIOLOGICAL | 0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1 |
| 24 valent pneumococcal conjugate vaccine | BIOLOGICAL | 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| 20 valent pneumococcal conjugate vaccine | BIOLOGICAL | 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
Inclusion Criteria: * Male or female age 65 or older. * Able and willing to complete the informed consent process. * Available for clinical follow-up through the last study visit at 6 months after the study vaccination. * In good general health as determined by medical history, vital signs, physica...