3 Griffith University’s Clinical Trial Unit is looking for adults: 60 years of age or older In good general health No current immunodeficiency disease/condition No previous allergic reactions to vaccines HELP ADVANCE RESPIRATORY SYNCYTIAL VIRUS (RSV) RESEARCH BY JOINING THIS CLINICAL TRIAL Participants will be reimbursed for study-related time and travel Seeking Volunteers for an Investigational RSV Vaccine Trial Register your interest by scanning the QR code For more information email clinicaltrialunit@griffith.edu.au VAE00017_Poster_2_GUCTU_v1.0_06Feb24 Why is this study being conducted? The purpose of the study is to evaluate the safety and immunogenicity of a respiratory syncytial virus (RSV) mRNA vaccine candidate in adult participants 60 years of age and older. Respiratory syncytial virus is a leading cause of respiratory illness in adults (second to the flu) with no specific treatment options. Who is eligible to participate in this study? Men and women 60 years of age or older who: • Are in good general health • Have no current immunodeficiency disease/ condition • Have not had previous allergic reactions to vaccines Applicants who express interest in participating in this study will be reviewed and contacted as other requirement criteria must also be met. What happens during the study? At the first visit the study doctor and staff will ask participants questions to determine their eligibility to participate in the study, and if all requirement criteria are met, participants will be assigned to a treatment group. Vaccine assignment Each participant will be assigned by chance (like the flipping of a coin) to the study vaccine or placebo vaccine. Participants will have a 1 out of 2 chance of receiving the study vaccine and a 1 out of 2 chance of receiving the placebo vaccine. What Participants will need to do Participation in this study will involve around 2 onsite clinic visits (or 3 onsite clinic visits if participants are included in an Immunogenicity Subset), 2 scheduled phone contacts for safety follow up (or 1 scheduled phone contact if participants are included in an Immunogenicity Volunteers Needed for RSV mRNA Vaccine Study Subset), and active surveillance contacts (phone, email or text) every two weeks to check if participants have experienced any respiratorylike illness, over a 6 month period. Why should individuals consider participating in this study? If a person is eligible to participate, his/her data may help the research team learn more to advance the development of a vaccine that may protect against disease caused by the RSV virus. Respiratory syncytial virus is a leading cause of respiratory illness in adults (second to the flu) with no specific prevention or treatment options. While RSV can infect anyone, for some people, especially babies, older adults, and those with heart or lung problems or weakened immune systems, symptoms can be more severe. RSV infection can cause problems like worsening congestive heart failure (when your heart can’t pump enough oxygen to your body) or pneumonia (an infection of the lungs). Participation in this study is completely voluntary, and participants can decide to withdraw at any time. Eligible participants will be reimbursed for their time and travel associated with each study visit. For further information please contact Clinical Trial Coordinator, Cassandra Balinas +61 7 567 80362 or email: clinicaltrialunit@griffith.edu.au.
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