drugset / Trial / NCT04645966
A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants
RandomizedFactorialDouble-blindPrevention
Summary
The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.
Timeline
- Start
- 2020-11-26
- Primary completion
- 2022-09-15
- Completion
- 2022-09-15
Outcome
Outcome not reported
Stopped: “The Sponsor decided to discontinue the study based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bexsero | Vaccine | — | — |
| Subject | Bivalent rLP2086 | Vaccine | 60 ug | — |
| Subject | Bivalent rLP2086 | Vaccine | 120 ug | — |
| Subject | MenABCWY | Vaccine | — | — |
| Subject | Nimenrix | Vaccine | — | — |
| Background | Acetaminophen | Small molecule | — | — |