drugset / Trial / NCT06181292

Safety and Immunogenicity of a Booster Vaccination With an Adapted Vaccine

NCT06181292

Phase 2/3 Completed 913 enrolled Hipra Scientific, S.L.U
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

EvaluationDrugModalityDoseRoute
Comparator Comirnaty Omicron XBB1.5 Vaccine 30 ug Intramuscular
Subject PHH-1V81 Protein / enzyme biologic 40 ug Intramuscular

Indications