Pneumonia, BacterialPhase 1NCT07105722
A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age
A Phase 1 study testing Pn-MAPS30plus and PCV20 in people with Pneumonia, Bacterial, run by GlaxoSmithKline at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Bacterial
- What is being tested?
- Pn-MAPS30plus and PCV20
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 4 sitesAustralia
- Study dates
- 12 Aug 2025to 6 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any trial-specific procedure.
- Healthy male and female participants between and including 50 through 64 YOA at the time of Informed consent form (ICF) signature.
- Female participants of childbearing potential may be enrolled if they practice adequate contraception and have a negative pregnancy test prior to study intervention administration.
Who cannot join
- History of microbiologically proven Invasive Pneumococcal Disease (IPD) caused by S. pneumoniae within the past 3 years.
- 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 history of Human immunodeficiency virus (HIV)-positive participant.
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- 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 trial participation.
- History of potential immune-mediated disorders (pIMDs).
- 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 during the period beginning 30 days before the study intervention administration.
- History of previous vaccination with any pneumococcal vaccine.
- 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.
- 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.
- Pregnant or lactating female participant.
- History of chronic alcohol consumption and/or drug abuse, based on investigator judgment.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
GSK Investigational Site
Bayswater, Victoria, 3153
GSK Investigational Site
Camberwell, Victoria, 3124
GSK Investigational Site
East Melbourne, Victoria, 3002
GSK Investigational Site
Norwood, South Australia, 5067
About this study
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
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.
- Conditions
- Pneumonia, Bacterial
- Being tested
- Pn-MAPS30plus, PCV20
- Keywords
- Streptococcus pneumoniae, Pn-MAPS30plus, 20 valent pneumococcal conjugate vaccine (PCV20)
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pn-MAPS30plusBiological
The Pn-MAPS30plus vaccine will be administered intramuscularly.
PCV20Combination product
The PCV20 vaccine will be administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Pn-MAPS30plus Group | Experimental | Participants receive a single dose of Pn-MAPS30plus on Day 1. Receives: Biological: Pn-MAPS30plus |
| PCV20 Group | Active comparator | Participants receive a single dose of PCV20 on Day 1. Receives: Combination Product: PCV20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Each Solicited Administration Site (Local) Event
Measured: Day 1 (post-vaccination) to Day 7
Number of Participants with Each Solicited Systemic Event
Measured: Day 1 (post-vaccination) to Day 7
Number of Participants with Any Unsolicited Adverse Events (AEs)
Measured: 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
Measured: Day 1 up to trial end (Month 6)
Number of Participants with Hematological and Biochemical Laboratory Abnormalities
Measured: On Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start12 Aug 2025
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105722
- Sponsor's protocol ID
- 221544
- Status last verified
- Jun 2026
- First submitted
- 4 Aug 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07105722
- Acronym / sponsor ID
- 221544
- Conditions
- Pneumonia, Bacterial
- Keywords
- Streptococcus pneumoniae, Pn-MAPS30plus, 20 valent pneumococcal conjugate vaccine (PCV20)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pn-MAPS30plus Group | Experimental | Biological: Pn-MAPS30plusParticipants receive a single dose of Pn-MAPS30plus on Day 1. |
| PCV20 Group | Active comparator | Combination Product: PCV20Participants receive a single dose of PCV20 on Day 1. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any trial-specific procedure.
- Healthy male and female participants between and including 50 through 64 YOA at the time of Informed consent form (ICF) signature.
- Female participants of childbearing potential may be enrolled if they practice adequate contraception and have a negative pregnancy test prior to study intervention administration.
Key exclusion criteria (17 listed)
- History of microbiologically proven Invasive Pneumococcal Disease (IPD) caused by S. pneumoniae within the past 3 years.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pn-MAPS30plusThe Pn-MAPS30plus vaccine will be administered intramuscularly. | Biological | Pn-MAPS30plus Group |
| PCV20The PCV20 vaccine will be administered intramuscularly. | Combination product | PCV20 Group |
Primary outcome
Number of Participants with Each Solicited Administration Site (Local) Event
Time frame: Day 1 (post-vaccination) to Day 7
Number of Participants with Each Solicited Systemic Event
Time frame: Day 1 (post-vaccination) to Day 7
Number of Participants with Any Unsolicited Adverse Events (AEs)
Time frame: 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
Time frame: Day 1 up to trial end (Month 6)
Number of Participants with Hematological and Biochemical Laboratory Abnormalities
Time frame: On Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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Pneumococcal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pn-MAPS30plus and PCV20 in people with Pneumonia, Bacterial, run by GlaxoSmithKline at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Each Solicited Administration Site (Local) Event (time frame: Day 1 (post-vaccination) to Day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.