drugset / Trial / NCT06181292
Safety and Immunogenicity of a Booster Vaccination With an Adapted Vaccine
RandomizedParallel-groupTriple-blindPrevention
Summary
This is a phase IIb/III, double-blind, randomised, active-controlled, multi-centre, non-inferiority clinical trial that aims to determine safety, tolerability and immunogenicity of a booster vaccination with a recombinant protein receptor binding domain (RBD) fusion homodimer of XBB.1.16 adapted candidate against SARS-CoV-2 developed by HIPRA (PHH-1V81).
Timeline
- Start
- 2023-11-15
- Primary completion
- 2024-06-17
- Completion
- 2024-06-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Comirnaty Omicron XBB1.5 | Vaccine | 30 ug | Intramuscular |
| Subject | PHH-1V81 | Protein / enzyme biologic | 40 ug | Intramuscular |