A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in … (NCT07105722) | Clinical Trial Compass
Active — Not RecruitingPhase 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 range50 Years – 64 Years
SexALL
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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.
✕. 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.
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
✕. 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.