The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Subjects With Solicited Local Symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Solicited General Symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 1
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 3
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 7
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 30
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 31
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 33
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 37
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 60
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 180
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Timeframe: At Day 360
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
Timeframe: From Day 1 to Day 60
Number of Subjects With Unsolicited Adverse Events (AEs)
Timeframe: During the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Timeframe: From Day 0 to Day 360