drugset / Trial / NCT06720038
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 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 approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.
Timeline
- Start
- 2024-11-25
- Primary completion
- 2027-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | PCV20 | Vaccine | 0.5 ml | Intramuscular |
| Subject | VAX-31 | Vaccine | 0.5 ml | Intramuscular |
Indications
No indication recorded.