RecruitingPhase 1

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

South Africa45 participantsStarted 2026-05-15

Plain-language 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.

Who can participate

Age range

12 Months – 15 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 1 to Day 7

Number of Participants with Solicited Systemic Adverse Events (AEs)

Timeframe: Day 1 to Day 7

Number of Participants with Unsolicited AEs

Timeframe: Day 1 to Day 30

Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal

Timeframe: Day 1 up to trial end (Month 6)

Number of Participants with Hematological and Biochemical Laboratory Abnormalities

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

Trial details

NCT IDNCT07406334

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-22

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

View on ClinicalTrials.gov More Pneumonia, Bacterial trials

Plain-language summary

Who can participate

Age range

12 Months – 15 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

What they're measuring

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

Timeframe: Day 1 to Day 7

Number of Participants with Solicited Systemic Adverse Events (AEs)

Timeframe: Day 1 to Day 7

Number of Participants with Unsolicited AEs

Timeframe: Day 1 to Day 30

Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal

Timeframe: Day 1 up to trial end (Month 6)

Number of Participants with Hematological and Biochemical Laboratory Abnormalities

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