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Active, not recruitingNCT07406334Updated Sep 28, 2026

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 interventional study of Pn-MAPS30plus and PCV20 in Pneumonia, Bacterial, sponsored by GlaxoSmithKline. Active, not recruiting at 2 sites in South Africa. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Prevention

Updated Sep 28, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
12 Months to 15 Months
Sex
All
01

Study 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. PCV20 will be used as a comparator for this study.

02

Conditions studied

  • Pneumonia, Bacterial

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Keywords

  • Pneumococcal Vaccine
  • Phase 1
  • Pediatric
  • Booster dose
03

In context

Pneumonia, Bacterial

153 studies on the registry are indexed under Pneumonia, Bacterial; 27 are open to participants now.

This study's enrollment of 46 is below the median of 132 across 107 interventional studies indexed under Pneumonia, Bacterial.

Browse Pneumonia, Bacterial studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants' parent(s)/Legally acceptable representative [LAR(s)] who, in the opinion of the investigator, can and will comply with all protocol requirements.
  2. Written or witnessed/thumb printed obtained from the participants' parent(s)/LAR(s) prior any study-specific procedure is performed.
  3. A male or female between, and including, 12 to15 Months of age at the time of the study intervention administration.
  4. Healthy participants or medically stable patients as established by medical history and clinical examination before entering the study.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. History of any reaction or likely to be exacerbated by any component of the study intervention(s).
  2. Hypersensitivity to latex.
  3. History of microbiologically proven Invasive pneumococcal Disease (IPD).
  4. Any confirmed or suspected or immunodeficient condition, based on medical history and physical examination.
  5. Major congenital defects, as assessed by the investigator.
  6. Recurrent history or uncontrolled neurological disorders or any neuroinflammatory condition, congenital neurological conditions, encephalopathies, or seizures.
  7. Condition that in the judgment of the investigator would make intramuscular injection unsafe.
  8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  9. Use of any 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.
  10. Previous vaccination with any pneumococcal vaccine other than PCV10.
  11. Previous receipt of more than 2 pneumococcal vaccine doses (primary series or booster).
  12. Planned administration/administration of any inactivated or otherwise non- 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.
  13. 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.
  14. 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 : prednisone equivalent ≥0.5 mg/kg/day (maximum 20 mg/day) within 90 days prior for pediatric participants.
    • Inhaled and topical steroids are allowed.
  15. Concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-investigational intervention.
  16. Any child of trial personnel or their immediate dependents, family, or household members.
  17. Child in care.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Pn-MAPS30plus Group

    Participants receive a single dose of Pn-MAPS30plus on Day 1.

    Biological: Pn-MAPS30plus

  • Active comparator
    PCV20 Group

    Participants receive a single dose of PCV20 on Day 1.

    Combination Product: PCV20

Interventions

  • BiologicalPn-MAPS30plus

    Pn-MAPS30plus vaccine will be administered intramuscularly.

  • Combination productPCV20

    PCV20 vaccine will be administered intramuscularly.

06

What researchers measure

Primary outcomes

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

    The AEs considered are tenderness, redness, and swelling at the administration site.

    Time frame: Day 1 to Day 7

  2. Number of Participants with Solicited Systemic Adverse Events (AEs)

    The AEs considered are fever, irritability, loss of appetite and somnolence (sleepiness/drowsiness).

    Time frame: Day 1 to Day 7

  3. 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.

    Time frame: Day 1 to Day 30

  4. 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)

  5. Number of Participants with Hematological and Biochemical Laboratory Abnormalities

    Time frame: On Day 8 compared to Day 1 (pre-vaccination)

07

Study locations

2 sites
  • GSK Investigational Site
    Soweto, Johannesburg, Gauteng 2013, South Africa
  • GSK Investigational Site
    Pretoria, 0152, South Africa
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Data sharing details ↗ · www.gsk-studyregister.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2026 (actual). Primary completion is estimated for Feb 2027, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2026
First posted
Feb 12, 2026
StartActual
May 15, 2026
Primary completionEst.
Feb 22, 2027
CompletionEst.
Feb 22, 2027
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Sep 28, 2026
Enrollment
45 (estimated)→46 (actual)
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Recruiting→Active, not recruiting
    Enrollment 45 (estimated)→46 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07406334
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 12, 2026
Start date
May 15, 2026
Primary completion
Feb 22, 2027 (estimated)
Completion
Feb 22, 2027 (estimated)
Last update
Sep 28, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Pn-MAPS30plus

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