Last updated: 10/08/2025 12:12:09
A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age
GSK study ID
221544
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 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.
Primary purpose:
Prevention
Trial design:
Parallel
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of Participants with Each Solicited Administration Site (Local) Event
Timeframe: Day 1 (post-vaccination) to Day 7
Number of Participants with Each Solicited Systemic Event
Timeframe: Day 1 (post-vaccination) to Day 7
Number of Participants with Any Unsolicited Adverse Events (AEs)
Timeframe: Day 1 (post-vaccination) to Day 30
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)
Number of Participants with Hematological and Biochemical Laboratory Abnormalities
Timeframe: On Day 8
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
120
Primary completion date:
2026-18-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pneumonia, Bacterial
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2025 to June 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 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.
- 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).
Inclusion and exclusion criteria
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.
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
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