A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age
NCT ID: NCT07105722
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
127 participants
INTERVENTIONAL
2025-08-12
2026-06-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Pn-MAPS30plus Group
Participants receive a single dose of Pn-MAPS30plus on Day 1.
Pn-MAPS30plus
The Pn-MAPS30plus vaccine will be administered intramuscularly.
PCV20 Group
Participants receive a single dose of PCV20 on Day 1.
PCV20
The PCV20 vaccine will be administered intramuscularly.
Interventions
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Pn-MAPS30plus
The Pn-MAPS30plus vaccine will be administered intramuscularly.
PCV20
The PCV20 vaccine will be administered intramuscularly.
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
64 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Norwood, South Australia, Australia
GSK Investigational Site
Bayswater, Victoria, Australia
GSK Investigational Site
Camberwell, Victoria, Australia
GSK Investigational Site
East Melbourne, Victoria, Australia
Countries
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Other Identifiers
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221544
Identifier Type: -
Identifier Source: org_study_id