VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Timeframe: On Day 1
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Timeframe: Day 1 through day 8
Presence of unsolicited AEs reported through 28 days after vaccination
Timeframe: Day 1 through day 29
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination
Timeframe: SAE: Screening through day 181; AESI: Day 1 through day 181
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
Timeframe: Screening through day 8