drugset / Trial / NCT05844423
Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.
Timeline
- Start
- 2023-03-29
- Primary completion
- 2025-08-25
- Completion
- 2025-08-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | PCV20 | Vaccine | — | Intramuscular |
| Subject | VAX-24 | Vaccine | 1.1 ug | Intramuscular |
| Subject | VAX-24 | Vaccine | 2.2 ug | Intramuscular |
| Subject | VAX-24 | Vaccine | 4.4 ug | Intramuscular |
Indications
No indication recorded.