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Recruiting NCT07573462

A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants

Phase III Interventional Pneumococcal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PG4, 20-valent pneumococcal conjugate vaccine (20vPnC).
Who it may be relevant to
Registry conditions: Pneumococcal Disease. Basic parameters: 42 Days — 98 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A PHASE 3, RANDOMIZED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Overview

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®). This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. There are two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are: \- infants who are about 2 months of age About 2400 infants will be assigned by chance to one of the two groups to receive either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age. Infants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.

Interventions

  • Biological PG4
    Multivalent Pneumococcal Vaccine
  • Biological 20-valent pneumococcal conjugate vaccine (20vPnC)
    20-valent pneumococcal conjugate vaccine (20vPnC)

Primary outcome measures

  • Percentage of participants reporting local reactions within 7 days after each dose [Time frame: Day 7]
  • Percentage of participants reporting systemic events within 7 days after each dose [Time frame: Day 7]
  • Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3 [Time frame: Dose 1 to 1 month after Dose 3]
  • Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4 [Time frame: Dose 4 to 1 month after Dose 4]
  • Percentage of participants reporting serious adverse events (SAEs) [Time frame: Dose 1 to 6 months after Dose 4]

Eligibility criteria

Inclusion criteria

  • Infants who are about 2 months of age
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion criteria

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
  • Major known congenital malformation or serious chronic disorder.
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 19 centers
  • Starz Pediatrics — Estero
  • Innovate Research Centers, LLC — Fort Lauderdale
  • MacKoul Pediatrics Fort Myers — Fort Myers
  • Rophe Adult and Pediatric Medicine/SKYCRNG — Union City
  • Rosemark Women Care Specialists — Idaho Falls
  • Eagle Clinical Research — Chicago
  • Kentucky Pediatric/ Adult Research — Bardstown
  • LSU Health Shreveport Clinical Trials Office — Shreveport
  • … and 11 more centers
Canada · 2 centers
  • Milestone Research Inc. — London
  • Bluewater Clinical Research Group Inc. — Sarnia

Identifiers

NCT: NCT07573462 · C4931007 · 2025-523447-35-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗