A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and … (NCT07628049) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults
Australia1,808 participantsStarted 2026-06-03
Plain-language summary
The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.
Who can participate
Age range
18 Years – 80 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 are eligible to be included in the study only if all of the following criteria apply:
* Written informed consent obtained from the participant prior to performance of any study-specific procedure.
* Participants who can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications).
* Note: For OA participants, in case of physical incapacity that would preclude the self-completion of the eDiaries, either site staff can assist the participant (for activities performed during site visits) and/or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home). However, at no time will the site staff or caregiver evaluate the participant's health status while answering eDiaries or make decisions on behalf of the participant.
* Body Mass Index (BMI) between 18 kg/m\^2 and 33 kg/m\^2, inclusive.
Specific inclusion criteria for OA
* A male or female between and including, 60 to 80 YOA at the time of the study intervention administration.
* Healthy participants or medically stable patients as established by medical history, physical examination (and normal screening laboratory tests including Grade 1 laboratory abnormalities that are not-clinically significant in Phase 1 only).
Specific inclusion criteria for YA
* A male or female participant between and including 18 to 49 Y…
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
Timeframe: Day 1 to Day 7
2
Number of Participants Reporting Solicited Systemic Events
Timeframe: Day 1 to Day 7
3
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Timeframe: Day 1 to Day 30
4
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Timeframe: Day 1 to Month 12
5
Number of Participants Reporting Potential immune-mediated disorders (pIMDs)
Timeframe: Day 1 to Month 12
6
Number of Participants Reporting Serious Adverse Events (SAEs)
Timeframe: Day 1 to study end [Month 24 for OA groups (only the selected formulation group&its comparators), Month 12 for YA groups & OA groups (all other investigational vaccine formulation groups not selected for future clinical development&other comparators)]
7
Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities