Actively Recruiting

Phase 1
Age: 50Years - 64Years
All Genders
Healthy Volunteers
NCT07428759

Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years

Led by GlaxoSmithKline · Updated on 2026-04-16

120

Participants Needed

2

Research Sites

41 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years

Who Can Participate

Age: 50Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants able to comply with study requirements like completing electronic diaries and attending follow-up visits
  • Provided written or witnessed informed consent before any study procedures
  • Healthy or medically stable adults as confirmed by medical history and clinical exam
  • Male and female adults aged 50 to 64 years at consent
  • Female participants of childbearing potential must use adequate contraception and have a negative pregnancy test before vaccination
Not Eligible

You will not qualify if you...

  • History of invasive pneumococcal disease caused by S. pneumoniae within 3 years before vaccination
  • History of allergic reactions or hypersensitivity to any vaccine components
  • Confirmed or suspected immunosuppressive or immunodeficient conditions
  • Allergy to latex
  • Conditions preventing safe intramuscular vaccination or blood collection
  • Documented HIV-positive status
  • Acute or unstable chronic significant pulmonary, cardiovascular, liver, kidney, or metabolic conditions
  • Recurrent uncontrolled neurological or neuroinflammatory disorders
  • Behavioral, cognitive, or psychiatric disorders interfering with trial participation
  • Any other clinical condition posing additional risk
  • Use of investigational or non-registered products within 30 days before vaccination
  • Previous pneumococcal vaccination
  • Receipt or planned receipt of immunoglobulins or blood products within 90 days before or 30 days after vaccination
  • Chronic or planned use of immune-modifying drugs lasting more than 14 consecutive days
  • Pregnancy or lactation
  • History or current chronic alcohol or drug abuse as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

GSK Investigational Site

Norwood, South Australia, Australia, 5067

Actively Recruiting

2

GSK Investigational Site

Camberwell, Victoria, Australia, 3124

Actively Recruiting

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Research Team

U

US GSK Clinical Trials Call Center

CONTACT

E

EU GSK Clinical Trials Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years | DecenTrialz