A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy… (NCT06573281) | Clinical Trial Compass
CompletedPhase 1
A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years
United States, Australia, Spain213 participantsStarted 2024-09-30
Plain-language summary
The purpose of this study is to assess the reactogenicity, safety and immune response of various formulations of the RSV mRNA investigational vaccine administered in healthy participants 18-45 years of age.
Who can participate
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.
Inclusion Criteria:
* Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits).
* Written informed consent obtained from the participant prior to performance of any study-specific procedure.
* Healthy participants as established by medical history, clinical examination and laboratory assessment at screening.
* Male or female between and including 18 and 45 years of age at the time of enrollment into the study.
* Body mass index more than or equal to (\>=) 18 kg/m\^2 and less than (\<) 40 kg/m\^2.
* Female participants of non-childbearing potential may be enrolled in the study.
* Female participants of childbearing potential may be enrolled in the study if the participant:
* has practiced adequate contraception for 1 month prior to study intervention administration period, and
* has a negative pregnancy test (on urine sample) on the day of study intervention administration, and
* has agreed to continue adequate contraception during the entire treatment period and for at least 1 month after completion of the study intervention administration series.
Exclusion Criteria:
Medical conditions
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
* Hypersensitivity to latex.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examinat…
Questions worth asking your doctor
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
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.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants reporting solicited administration site events within 7 days post-Dose 1
Timeframe: From Day 1 to Day 7
2
Number of participants reporting solicited administration site events within 7 days post-Dose 2
Timeframe: From Day 30 to Day 36
3
Number of participants reporting solicited systemic events within 7 days post-Dose 1
Timeframe: From Day 1 to Day 7
4
Number of participants reporting solicited systemic events within 7 days post-Dose 2
Timeframe: From Day 30 to Day 36
5
Number of participants reporting unsolicited adverse events (AEs) within 29 days post-Dose 1
Timeframe: From Day 1 to Day 29
6
Number of participants reporting unsolicited AEs within 29 days post-Dose 2
Timeframe: From Day 30 to Day 58
7
Number of participants reporting serious adverse events (SAEs)