Pneumonia, Bacterial
Conditions
Keywords
Streptococcus pneumoniae, Pn-MAPS30plus, 20 valent pneumococcal conjugate vaccine (PCV20)
Brief 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.
Interventions
BIOLOGICALPn-MAPS30plus
The Pn-MAPS30plus vaccine will be administered intramuscularly.
COMBINATION_PRODUCTPCV20
The PCV20 vaccine will be administered intramuscularly.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
This trial will be conducted in an observer-blind manner.
Eligibility
Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. 2. Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any trial-specific procedure. 3. Healthy male and female participants between and including 50 through 64 YOA at the time of Informed consent form (ICF) signature. 4. 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
1. History of microbiologically proven Invasive Pneumococcal Disease (IPD) caused by S. pneumoniae within the past 3 years. 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 history of Human immunodeficiency virus (HIV)-positive participant. 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 trial participation. 10. History of potential immune-mediated disorders (pIMDs). 11. Any other clinical condition that, might pose additional risk to the participant. 12. Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the study intervention administration. 13. History of previous vaccination with any pneumococcal vaccine. 14. Receipt of blood or plasma products or immunoglobulins, from 90 days before study intervention administration, or planned receipt within 30 days of study intervention administration. 15. Chronic administration 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. 16. Pregnant or lactating female participant. 17. History of chronic alcohol consumption and/or drug abuse, based on investigator judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Each Solicited Systemic Event | Day 1 (post-vaccination) to Day 7 |
| Number of Participants with Any Unsolicited Adverse Events (AEs) | Day 1 (post-vaccination) to Day 30 |
| Number of Participants with Each Solicited Administration Site (Local) Event | Day 1 (post-vaccination) to Day 7 |
| Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal | Day 1 up to trial end (Month 6) |
| Number of Participants with Hematological and Biochemical Laboratory Abnormalities | On Day 8 |
Countries
Australia
Outcome results
None listed