The purpose of this study is to assess the safety, reactogenicity and immune response of the candidate CMV recombinant protein subunit (CMVsu) vaccine consisting of a combination of glycoproteins B (gB) and pentamer antigens adjuvanted, regardless of baseline CMV sero-status. This FTiH study will be conducted in healthy adults 18 to 50 years of age, in which the 4 dose levels of the vaccine will be administered in a step-wise dose escalation manner, based upon safety adjudication.
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Number of participants reporting solicited administration site events
Timeframe: Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting solicited systemic events
Timeframe: Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting unsolicited adverse events (AEs) within 7 days after each dose
Timeframe: Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting serious adverse events (SAEs) within 7 days after each dose
Timeframe: Within 7 days (the day of dose and 6 subsequent days) after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting unsolicited AEs up to 30 days after each dose
Timeframe: Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting SAEs up to 30 days after each dose
Timeframe: Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting medically attended AEs (MAEs) up to 30 days after each dose
Timeframe: Up to 30 days after each dose (vaccines administered on Day 1, Day 61 and Day 181)
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 1
Timeframe: At Day 1
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 8
Timeframe: At Day 8
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 61
Timeframe: At Day 61
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 68
Timeframe: At Day 68
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 181
Timeframe: At Day 181
Number of participants reporting hematological and biochemical laboratory abnormalities on Day 188
Timeframe: Day 188