Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults… (NCT07428759) | Clinical Trial Compass
RecruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Australia120 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 range50 Years – 64 Years
SexALL
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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
✕. 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.
✕
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)
✕. 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.