Last updated: 04/16/2026 12:10:11
Trial to Evaluate Safety and Immune response of an Investigational Pneumococcal Vaccine in Adults aged 50 To 64 Years
GSK study ID
300283
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: A Phase 1, Observer-Blind, Randomized, Active Controlled Trial to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of Participants with Solicited Administration Site Adverse Events (AEs)
Timeframe: Day 1 to Day 7
Number of Participants with Solicited Systemic AEs
Timeframe: Day 1 to Day 7
Number of Participants with Unsolicited AEs
Timeframe: Day 1 to Day 30
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: From Day 1 to Day 181 (study end)
Number of Participants with Adverse Events of Special Interest (AESIs)
Timeframe: From Day 1 to Day 181 (study end)
Number of Participants with AEs Leading to withdrawal from the study
Timeframe: From Day 1 to Day 181 (study end)
Number of Participants with any Laboratory abnormalities
Timeframe: Day 8 compared to Screening Visit (up to Day -14)
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Pn-MAPS30plus
Combination product: PCV20
Enrollment:
120
Observational study model:
Not applicable
Primary completion date:
2026-24-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pneumonia, Bacterial
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2026 to December 2026
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
50 - 64 Years
Accepts healthy volunteers
Yes
- 1. 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).
- 2. Written or witnessed/thumb printed informed consent obtained before any trial-specific procedure.
- 1. History of microbiologically proven invasive pneumococcal disease (IPD) caused by S. pneumoniae within 3 years before study intervention administration.
- 2. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
Inclusion and exclusion criteria
Inclusion criteria:
- 1. 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). 2. Written or witnessed/thumb printed informed consent obtained before any trial-specific procedure. 3. 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. 4. Male and female participants aged 50 and 64 years of age (YOA) at the time of Informed consent form (ICF) signature. 5. 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:
- 1. History of microbiologically proven invasive pneumococcal disease (IPD) caused by S. pneumoniae within 3 years before study intervention administration. 2. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). 3. Any confirmed or suspected immunosuppressive or immunodeficient condition. 4. Hypersensitivity to latex. 5. Clinical conditions representing a contraindication to intramuscular vaccination, and blood collection. 6. Documented HIV-positive status. 7. Acute or unstable chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, or metabolic conditions as determined by the investigator. 8. Recurrent history of uncontrolled neurological or any neuroinflammatory disorders. 9. Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant’s ability to participate in the trial. 10. Any other clinical condition that, might pose additional risk to the participant. 11. Use of any investigational or non-registered product other than the study interventions within 30 days before the study intervention administration. 12. History of previous vaccination with any pneumococcal vaccine. 13. Administration of immunoglobulins or other blood products or plasma derivatives within 90 days before or planned within 30 days after study intervention. 14. Chronic administrations of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the trial. 15. Pregnant or lactating female participant. 16. History of and/or current chronic alcohol consumption and/or drug abuse, based on investigator judgment.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website