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NCT Number: NCT07428759

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pneumonia, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Norwood, South Australia, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Written or witnessed/thumb printed informed consent obtained before any trial-specific procedure.
  • 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.
  • Male and female participants aged 50 and 64 years of age (YOA) at the time of Informed consent form (ICF) signature.
  • 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

  • History of microbiologically proven invasive pneumococcal disease (IPD) caused by S. pneumoniae within 3 years before study intervention administration.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition.
  • Hypersensitivity to latex.
  • Clinical conditions representing a contraindication to intramuscular vaccination, and blood collection.
  • Documented HIV-positive status.
  • Acute or unstable chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, or metabolic conditions as determined by the investigator.
  • Recurrent history of uncontrolled neurological or any neuroinflammatory disorders.
  • 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.
  • Any other clinical condition that, might pose additional risk to the participant.
  • Use of any investigational or non-registered product other than the study interventions within 30 days before the study intervention administration.
  • History of previous vaccination with any pneumococcal vaccine.
  • Administration of immunoglobulins or other blood products or plasma derivatives within 90 days before or planned within 30 days after study intervention.
  • 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.
  • Pregnant or lactating female participant.
  • History of and/or current chronic alcohol consumption and/or drug abuse, based on investigator judgment.

Treatment and study plan

Pn-MAPS30plus

Biological

Single dose of Pn-MAPS30plus received intramuscularly.

PCV20

Combination Product

Single dose of PCV20 received intramuscularly.

Primary outcomes

  1. Number of Participants with Solicited Administration Site Adverse Events (AEs)

    Time frame: Day 1 to Day 7

    The solicited administration site AEs considered are pain, redness and swelling.

  2. Number of Participants with Solicited Systemic AEs

    Time frame: Day 1 to Day 7

    The solicited systemic AEs considered are fever, headache, fatigue (tiredness), myalgia (muscle pain), and arthralgia (joint pain).

  3. Number of Participants with Unsolicited AEs

    Time frame: Day 1 to Day 30

    An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

  4. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: From Day 1 to Day 181 (study end)

    SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.

  5. Number of Participants with Adverse Events of Special Interest (AESIs)

    Time frame: From Day 1 to Day 181 (study end)

  6. Number of Participants with AEs Leading to withdrawal from the study

    Time frame: From Day 1 to Day 181 (study end)

  7. Number of Participants with any Laboratory abnormalities

    Time frame: Day 8 compared to Screening Visit (up to Day -14)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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