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NCT Number: NCT07406347

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

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

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Key information

Age range

42 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • Previous vaccination with any pneumococcal vaccine.
  • 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.
  • 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.
  • 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.
  • 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.

Treatment and study plan

Pn-MAPS30plus

Biological

Pn-MAPS30plus vaccine will be administered intramuscularly.

PCV20

Combination Product

PCV20 vaccine will be administered intramuscularly.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  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 16)

Study contacts

Contact information is provided by the study sponsor or research team.

EU GSK Clinical Trials Call Center

CONTACT

[email protected]

+44 (0) 20 89904466

US GSK Clinical Trials Call Center

CONTACT

[email protected]

877-379-3718

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Feb 12, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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