drugset / Trial / NCT06177912
A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as infants/toddlers. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting pneumococcal disease (PD).
Timeline
- Start
- 2024-01-18
- Primary completion
- 2025-02-26
- Completion
- 2025-02-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pneumovax 23 | Vaccine | 0.5 ml | Intramuscular |
| Subject | V116 | Vaccine | 0.5 ml | Intramuscular |