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).
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Number, percentage and characteristics of solicited local and systemic AEs, unsolicited AEs, SAEs, AESIs and MAAEs
Timeframe: 0, 7, 14, 91 and 182 days post-vaccination
Neutralising antibody titers of PHH-1V81 booster at Day 0 and 14
Timeframe: 0 and 14 days post-vaccination