Pneumonia, BacterialPhase 1NCT07406334
A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months of Age Receiving a Single Booster Dose
A Phase 1 study testing Pn-MAPS30plus and PCV20 in people with Pneumonia, Bacterial, run by GlaxoSmithKline at 2 sites in South Africa.
Trial summary
The main purpose of this study is to assess the safety and reactogenicity of a single dose of the new pneumococcal vaccine (called Pn-MAPS30plus) in toddlers who have previously completed a two-dose primary vaccination series with PCV used in local immunization program. Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy 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
- 46 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 15 May 2026to 22 Feb 2027
- 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 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants' parent(s)/Legally acceptable representative [LAR(s)] who, in the opinion of the investigator, can and will comply with all protocol requirements.
- Written or witnessed/thumb printed informed consent obtained from the participants' parent(s)/LAR(s) prior any study-specific procedure is performed.
- A male or female between, and including, 12 to15 Months of age at the time of the study intervention administration.
- Healthy participants or medically stable patients as established by medical history and clinical examination before entering the study.
- To the best knowledge of the participant's parent(s)/LAR(s), the child has been eligible for pneumococcal vaccination and has completed a 2-dose primary series with PCV10.
Who cannot join
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- Hypersensitivity to latex.
- History of microbiologically proven Invasive pneumococcal Disease (IPD).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Major congenital defects, as assessed by the investigator.
- Recurrent history or uncontrolled neurological disorders or any neuroinflammatory condition, congenital neurological conditions, encephalopathies, or seizures.
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- Condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the trial period.
- Previous vaccination with any pneumococcal vaccine other than PCV10.
- Previous receipt of more than 2 pneumococcal vaccine doses (primary series or booster).
- Planned administration/administration of any inactivated or otherwise non-live vaccine in the period starting 14 days before and ending 14 days after the dose of study intervention administration or planned administration/administration of any live vaccine in the period starting 28 days before and ending 28 days after the dose of study intervention administration, with the exception of inactivated influenza vaccine which may be administered but must be given at least 7 days before or 15 days after receipt of any study intervention.
- Receipt of blood or plasma products or immunoglobulins, from 90 days before study intervention administration, or planned receipt up to 30 days of study intervention administration.
- Chronic administration of immune-modifying drugs and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
- For corticosteroids: prednisone equivalent ≥0.5 mg/kg/day (maximum 20 mg/day) within 90 days prior for pediatric participants.
- Inhaled and topical steroids are allowed.
- Concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-investigational intervention.
- Any child of trial personnel or their immediate dependents, family, or household members.
- Child in care.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
GSK Investigational Site
Pretoria, 0152
GSK Investigational Site
Soweto, Johannesburg, Gauteng, 2013
About this study
Official title: A Phase 1, Observer-Blind, Randomized, Active Controlled Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 To 15 Months of Age Receiving a Single Booster Dose
The main purpose of this study is to assess the safety and reactogenicity of a single dose of the new pneumococcal vaccine (called Pn-MAPS30plus) in toddlers who have previously completed a two-dose primary vaccination series with PCV used in local immunization program. PCV20 will be used as a comparator for this study.
- Conditions
- Pneumonia, Bacterial
- Being tested
- Pn-MAPS30plus, PCV20
- Keywords
- Pneumococcal Vaccine, Phase 1, Pediatric, Booster dose
- 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
Pn-MAPS30plus vaccine will be administered intramuscularly.
PCV20Combination product
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 Solicited Administration site Adverse Events (AEs)
The AEs considered are tenderness, redness, and swelling at the administration site.
Measured: Day 1 to Day 7
Number of Participants with Solicited Systemic Adverse Events (AEs)
The AEs considered are fever, irritability, loss of appetite and somnolence (sleepiness/drowsiness).
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 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 compared to Day 1 (pre-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start15 May 2026
- Primary completion22 Feb 2027 (estimated)
- Study completion22 Feb 2027 (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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406334
- Sponsor's protocol ID
- 221546
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 28 Sep 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 28 Sep 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 Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 To 15 Months of Age Receiving a Single Booster Dose
- ClinicalTrials.gov ID
- NCT07406334
- Acronym / sponsor ID
- 221546
- Conditions
- Pneumonia, Bacterial
- Keywords
- Pneumococcal Vaccine, Phase 1, Pediatric, Booster dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 May 2026 (actual)
- Primary completion
- 22 Feb 2027 (estimated)
- Study completion
- 22 Feb 2027 (estimated)
- First posted
- 12 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.
The main purpose of this study is to assess the safety and reactogenicity of a single dose of the new pneumococcal vaccine (called Pn-MAPS30plus) in toddlers who have previously completed a two-dose primary vaccination series with PCV used in local immunization program. PCV20 will be used as a comparator for this study.
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
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participants' parent(s)/Legally acceptable representative [LAR(s)] who, in the opinion of the investigator, can and will comply with all protocol requirements.
- Written or witnessed/thumb printed informed consent obtained from the participants' parent(s)/LAR(s) prior any study-specific procedure is performed.
- A male or female between, and including, 12 to15 Months of age at the time of the study intervention administration.
- Healthy participants or medically stable patients as established by medical history and clinical examination before entering the study.
- To the best knowledge of the participant's parent(s)/LAR(s), the child has been eligible for pneumococcal vaccination and has completed a 2-dose primary series with PCV10.
Key exclusion criteria (19 listed)
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- Hypersensitivity to latex.
- History of microbiologically proven Invasive pneumococcal Disease (IPD).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Major congenital defects, as assessed by the investigator.
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-MAPS30plusPn-MAPS30plus vaccine will be administered intramuscularly. | Biological | Pn-MAPS30plus Group |
| PCV20PCV20 vaccine will be administered intramuscularly. | Combination product | PCV20 Group |
Primary outcome
Number of Participants with Solicited Administration site Adverse Events (AEs)
Time frame: Day 1 to Day 7
The AEs considered are tenderness, redness, and swelling at the administration site.
Number of Participants with Solicited Systemic Adverse Events (AEs)
Time frame: Day 1 to Day 7
The AEs considered are fever, irritability, loss of appetite and somnolence (sleepiness/drowsiness).
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 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 compared to Day 1 (pre-vaccination)
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 28 Sep 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 South Africa.
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 19 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 28 Sep 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 South Africa. 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 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 28 Sep 2026.