A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in … (NCT07105722) | Clinical Trial Compass
CompletedPhase 1
A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age
Australia127 participantsStarted 2025-08-12
Plain-language summary
This clinical study is designed to evaluate an investigational pneumococcal vaccine named Pn-MAPS30plus. The vaccine is designed to stimulate the immune system to produce antibodies against various serotypes of the S. pneumoniae bacteria, potentially aiding the body in fighting infection upon exposure. Pn-MAPS30plus aims to broaden protection by covering more serotypes than currently licensed pneumococcal vaccines. The study's purpose is to determine whether the vaccine is safe, well-tolerated, and effective in inducing immune responses against S. pneumoniae.
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 and will comply with the requirements of the protocol.
. Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any trial-specific procedure.
. Healthy male and female participants between and including 50 through 64 YOA at the time of Informed consent form (ICF) signature.
. Female participants of childbearing potential may be enrolled if they practice adequate contraception and have a negative pregnancy test prior to study intervention administration.
Exclusion criteria
. History of microbiologically proven Invasive Pneumococcal Disease (IPD) caused by S. pneumoniae within the past 3 years.
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 Each Solicited Administration Site (Local) Event
Timeframe: Day 1 (post-vaccination) to Day 7
2
Number of Participants with Each Solicited Systemic Event
Timeframe: Day 1 (post-vaccination) to Day 7
3
Number of Participants with Any Unsolicited Adverse Events (AEs)
Timeframe: Day 1 (post-vaccination) to Day 30
4
Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal
Timeframe: Day 1 up to trial end (Month 6)
5
Number of Participants with Hematological and Biochemical Laboratory Abnormalities
. 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 history of Human immunodeficiency virus (HIV)-positive participant.
. 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.