This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.
Age range
60 Years
Sex
ALL
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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.
RSV A serum nAb (neutralizing antibodies) titers
Timeframe: At Day 1 and Day 29
RSV B serum nAb titers
Timeframe: At Day 1 and Day 29
HMPV A serum nAb titers
Timeframe: At Day 1 and Day 29
HMPV B serum nAb titers
Timeframe: At Day 1 and Day 29
Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination
Timeframe: Within 30 minutes after vaccination
Presence of solicited injection site and systemic reactions
Timeframe: For 8 days, including the day of vaccination
Presence of Unsolicited AEs
Timeframe: For 28 days, including day of vaccination
Trial Transparency email recommended (Toll free for US & Canada)
Presence of medically attended AEs (MAAEs)
Timeframe: Within 6 months after vaccination
Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs)
Timeframe: Throughout the study (approximately 12 months)
Presence of out-of-range biological test results
Timeframe: At Day 09