Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respir… (NCT07071558) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
Australia240 participantsStarted 2025-07-14
Plain-language summary
The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49 years of age.
-Each participant will remain in the study for approximately 6 months.
* The study intervention will be administered as a single intramuscular (IM) dose in the upper arm on Day 1 (D01).
* The visit frequency will include 1 Screening Visit, 4 planned site visits to occur on D01, D03, D08, and D29, and 2 telephone calls to occur at Month (M)3 and M6.
Who can participate
Age range
18 Years – 49 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:
* Aged 18 to 49 years on the day of inclusion
* A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:
* Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR
* Is of CBP (Child-Bearing Potential) and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
Exclusion Criteria:
* Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
Presence of any unsolicited systemic adverse events (aes)
Timeframe: Within 30 minutes after each vaccine injection
2
Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form)
Timeframe: Through 7 days after each vaccine injection
3
Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF)
Timeframe: Through 7 days after each vaccine injection
4
Presence of unsolicited AEs
Timeframe: Day 1 through day 29
5
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest)
Timeframe: Throughout study, approximately 6 months
6
Presence of out-of-range biological test results (including shift from baseline values)
Timeframe: Through 7 days after each vaccine injection