The objectives of this first-in-human is to evaluate the safety and the immunogenicity of three administrations of a bivalent vaccine candidate against human cytomegalovirus, at three different dose levels.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety primary outcome (local solicited symptoms)
Timeframe: Day 0 to Day 7 after each administration
Safety primary outcome (general solicited symptoms)
Timeframe: Day 0 to Day 7 after each administration
Safety primary outcome (Unsolicited AE´s)
Timeframe: From Day 0 to Month 4
Safety primary outcome (SAEs and pregnancies)
Timeframe: From Day 0 to Month 12
Safety primary outcome (Vital signs)
Timeframe: From Day 0 to Month 12
Safety primary outcome (physical examination)
Timeframe: From Day 0 to Month 12
Safety primary outcome (Clinical evaluation - part I)
Timeframe: From Day 0 to Month 12
Safety primary outcome (Clinical evaluation - part II)
Timeframe: From Day 0 to Month 12