Not Yet RecruitingPhase 1

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

60 participantsStarted 2026-07-10

Plain-language summary

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

Who can participate

Age range42 Days – 90 Days

SexALL

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 to performance of any study-specific procedure.
✓. Participant is approximately 2 Months of Age \[MOA (42 to 90 days, inclusive)\] at time of first study intervention administration.
✓. Healthy participants as established by medical history and clinical examination before entering the trial.
✓. Participant is a full-term infant (≥37 weeks gestation at birth) with a birth weight of \>2.5 kg.

Exclusion criteria

✕. 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.
✕. 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.

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 16)

Trial details

NCT IDNCT07406347

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-03

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

View on ClinicalTrials.gov More Pneumonia, Bacterial trials

Who can participate

Age range42 Days – 90 Days

SexALL

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 to performance of any study-specific procedure.
✓. Participant is approximately 2 Months of Age \[MOA (42 to 90 days, inclusive)\] at time of first study intervention administration.
✓. Healthy participants as established by medical history and clinical examination before entering the trial.
✓. Participant is a full-term infant (≥37 weeks gestation at birth) with a birth weight of \>2.5 kg.

Exclusion criteria

✕. 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.
✕. 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.

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 16)