A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age

A Phase 1, Observer-blind, Randomized, Active Controlled Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age

The main purpose of this study is to evaluate safety and reactogenicity of the investigational pneumococcal vaccine (called Pn-MAPS30plus). PCV20 will be used as a comparator for this study

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia, Bacterial
• Intervention / Treatment: Biological: Pn-MAPS30plus; Combination product: PCV20

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: US GSK Clinical Trials Call Center; Phone Number: 877-379-3718; Email: GSKClinicalSupportHD@gsk.com
• Study Contact Backup: Name: EU GSK Clinical Trials Call Center; Phone Number: +44 (0) 20 89904466; Email: GSKClinicalSupportHD@gsk.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 informed consent obtained from the participants' parent(s)/LAR(s) prior to performance of any study-specific procedure.
3. Participant is approximately 2 Months of Age [MOA (42 to 90 days, inclusive)] at time of first study intervention administration.
4. Healthy participants as established by medical history and clinical examination before entering the trial.
5. Participant is a full-term infant (≥37 weeks gestation at birth) with a birth weight of >2.5 kg.

Exclusion Criteria:

1. History of any reaction or hypersensitivity 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 immunosuppressive 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 investigational or non-registered product (drug, vaccine, or invasive medical device in the country of enrollment) other than the study intervention(s) 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.
11. Planned administration/administration of any inactivated or otherwise non live vaccine in the period starting 14 days before and ending 14 days after each 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 each dose of study intervention(s) 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.
12. Receipt of blood or plasma products or immunoglobulins, since birth, or planned receipt during the trial up to 30 days after last study intervention administration.
13. 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 trial since birth. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum of 20 mg/day. Inhaled and topical steroids are allowed.
14. Concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-investigational intervention.
15. Any child of trial personnel or their immediate dependents, family, or household members.
16. Child in care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pn-MAPS30plus Group; Participants receive three primary doses of Pn-MAPS30plus on Day 1, Day 61, Day 121 and a booster dose on Day 301.	Biological: Pn-MAPS30plus; Pn-MAPS30plus vaccine will be administered intramuscularly.
Active Comparator: PCV20 Group; Participants receive three primary doses of PCV20 on Day 1, Day 61, Day 121 and a booster dose on Day 301.	Combination product: PCV20; PCV20 vaccine will be administered intramuscularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with solicited administration site adverse events (AEs)	The AEs considered are tenderness, redness, and swelling.	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).	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.	Day 1 to Day 30
Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal		Day 1 up to trial end (Month 16)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): April 3, 2028
• Study Completion (Estimated): April 3, 2028

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric; Phase 1; Infants; Pneumococcal Vaccine; Primary and Booster vaccination
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia, Bacterial
• Other Study ID Numbers: 221547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No