Pneumonia, BacterialPhase 1NCT07428759
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
A Phase 1 study testing Pn-MAPS30plus and PCV20 in people with Pneumonia, Bacterial, run by GlaxoSmithKline at 2 sites in Australia.
Trial summary
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… 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
- 122 participants
- Where
- 2 sitesAustralia
- Study dates
- 10 Mar 2026to 19 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 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.
Who cannot join
- 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.
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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 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
GSK Investigational Site
Camberwell, Victoria, 3124
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 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
- Pneumonia, Bacterial
- Being tested
- Pn-MAPS30plus, PCV20
- Keywords
- Pn-MAPS30plus, MAPS technology, pneumococcal vaccine, Phase 1, Healthy Adults, 50-64 years
- 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
Single dose of Pn-MAPS30plus received intramuscularly.
PCV20Combination product
Single dose of PCV20 received intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pn- MAPS30plus | Experimental | Participants receive a single dose of Pn-MAPS30plus vaccine at Day 1. Receives: Biological: Pn-MAPS30plus |
| Group 2: PCV20 | Active comparator | Participants receive a single dose of PCV20 (20-valent pneumococcal conjugate vaccine) at 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 Solicited Administration Site Adverse Events (AEs)
The solicited administration site AEs considered are pain, redness and swelling.
Measured: Day 1 to Day 7
Number of Participants with Solicited Systemic AEs
The solicited systemic AEs considered are fever, headache, fatigue (tiredness), myalgia (muscle pain), and arthralgia (joint pain).
Measured: Day 1 to Day 7
Number of Participants with Unsolicited AEs
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.
Measured: Day 1 to Day 30
Number of Participants with Serious Adverse Events (SAEs)
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.
Measured: From Day 1 to Day 181 (study end)
Number of Participants with Adverse Events of Special Interest (AESIs)
Measured: From Day 1 to Day 181 (study end)
Number of Participants with AEs Leading to withdrawal from the study
Measured: From Day 1 to Day 181 (study end)
Number of Participants with any Laboratory abnormalities
Measured: Day 8 compared to Screening Visit (up to Day -14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start10 Mar 2026
- Primary completion19 Nov 2026 (estimated)
- Study completion19 Nov 2026 (estimated)
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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428759
- Sponsor's protocol ID
- 300283
- Status last verified
- Oct 2026
- First submitted
- 17 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 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
- NCT07428759
- Acronym / sponsor ID
- 300283
- Conditions
- Pneumonia, Bacterial
- Keywords
- Pn-MAPS30plus, MAPS technology, pneumococcal vaccine, Phase 1, Healthy Adults, 50-64 years
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 19 Nov 2026 (estimated)
- Study completion
- 19 Nov 2026 (estimated)
- First posted
- 24 Feb 2026 (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 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.
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 |
|---|---|---|
| Group 1: Pn- MAPS30plus | Experimental | Biological: Pn-MAPS30plusParticipants receive a single dose of Pn-MAPS30plus vaccine at Day 1. |
| Group 2: PCV20 | Active comparator | Combination Product: PCV20Participants receive a single dose of PCV20 (20-valent pneumococcal conjugate vaccine) at Day 1. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
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-MAPS30plusSingle dose of Pn-MAPS30plus received intramuscularly. | Biological | Group 1: Pn- MAPS30plus |
| PCV20Single dose of PCV20 received intramuscularly. | Combination product | Group 2: PCV20 |
Primary outcome
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.
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).
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.
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.
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: From Day 1 to Day 181 (study end)
Number of Participants with AEs Leading to withdrawal from the study
Time frame: From Day 1 to Day 181 (study end)
Number of Participants with any Laboratory abnormalities
Time frame: Day 8 compared to Screening Visit (up to Day -14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 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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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.
2 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 2 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 5 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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 Solicited Administration Site Adverse Events (AEs) (time frame: Day 1 to Day 7). The study lists 7 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 27 Oct 2026.