Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults… (NCT07428759) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Australia121 participantsStarted 2026-03-10
Plain-language summary
This study will evaluate the safety and immune response of a new formulation of pneumococcal vaccine, PnMAPS30plus, in healthy adults aged 50 to 64 years. Participants will receive a single dose of either the investigational vaccine or an approved pneumococcal vaccine (PCV20) and will be monitored for approximately six months. The study aims to determine if PnMAPS30plus is safe and well-tolerated and whether it helps the body produce antibodies that protect against pneumococcal disease.
Who can participate
Age range
50 Years – 64 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 comply with the requirements (e.g., completion of the electronic diary \[eDiary\], return for follow-up visits).
. Written or witnessed/thumb printed informed consent obtained before any trial-specific procedure.
. Healthy or medically stable adults confirmed by medical history and clinical examination at screening. Participants with stable medical conditions can be enrolled at the discretion of the investigator.
. Male and female participants aged 50 and 64 years of age (YOA) at the time of Informed consent form (ICF) signature.
. Female participants of childbearing potential (POCBP) may enrol if they practice adequate contraception and have a negative pregnancy test prior to study intervention administration.
Exclusion criteria
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 with Solicited Administration Site Adverse Events (AEs)
Timeframe: Day 1 to Day 7
2
Number of Participants with Solicited Systemic AEs
Timeframe: Day 1 to Day 7
3
Number of Participants with Unsolicited AEs
Timeframe: Day 1 to Day 30
4
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: From Day 1 to Day 181 (study end)
5
Number of Participants with Adverse Events of Special Interest (AESIs)
Timeframe: From Day 1 to Day 181 (study end)
6
Number of Participants with AEs Leading to withdrawal from the study
Timeframe: From Day 1 to Day 181 (study end)
7
Number of Participants with any Laboratory abnormalities
Timeframe: Day 8 compared to Screening Visit (up to Day -14)
. History of microbiologically proven invasive pneumococcal disease (IPD) caused by S. pneumoniae within 3 years before study intervention administration.
. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
. Any confirmed or suspected immunosuppressive or immunodeficient condition.
. Hypersensitivity to latex.
. Clinical conditions representing a contraindication to intramuscular vaccination, and blood collection.
. Documented HIV-positive status.
. Acute or unstable chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, or metabolic conditions as determined by the investigator.
. Recurrent history of uncontrolled neurological or any neuroinflammatory disorders.