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

NCT07573462
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
clinicaltrials.gov
Participants
2,400
clinicaltrials.gov
Lead sponsor
Pfizer
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Start date
2026-05-04
clinicaltrials.gov
Number of sites
25
clinicaltrials.gov

Summary
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.
clinicaltrials.gov
Short title
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
clinicaltrials.gov
Official title
A PHASE 3, RANDOMIZED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 3
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Study type
Interventional
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Completion date
2028-12-30
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First posted
2026-05-07
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Registry last updated
2026-08-10
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Primary completion date
2028-12-30
clinicaltrials.gov
Start date
2026-05-04
clinicaltrials.gov

Participants
2,400
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
2,400
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Protocol amendments
1
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Number of sites
25
clinicaltrials.gov

Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07573462
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07573462
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percentage of participants reporting local reactions within 7 days after each dose

    Timeframe: Day 7

    Prompted local reactions after each dose

  2. Percentage of participants reporting systemic events within 7 days after each dose

    Timeframe: Day 7

    Prompted systemic events after each dose

  3. Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3

    Timeframe: Dose 1 to 1 month after Dose 3

    AEs occurring from Dose 1 to 1 month after Dose 3

  4. Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4

    Timeframe: Dose 4 to 1 month after Dose 4

    AEs occurring from Dose 4 to 1 month after Dose 4

  5. Percentage of participants reporting serious adverse events (SAEs)

    Timeframe: Dose 1 to 6 months after Dose 4

    SAEs occurring from Dose 1 to 6 months after Dose 4

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
42 Days
Maximum age
98 Days
Healthy volunteers
Yes

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Starz PediatricsEstero, United StatesRecruiting
  • Innovate Research Centers, LLCFort Lauderdale, United StatesRecruiting
  • MacKoul Pediatrics Fort MyersFort Myers, United StatesRecruiting
  • Rophe Adult and Pediatric Medicine/SKYCRNGUnion City, United StatesRecruiting
  • Rosemark Women Care SpecialistsIdaho Falls, United StatesRecruiting
  • Eagle Clinical ResearchChicago, United StatesRecruiting
  • Kentucky Pediatric/ Adult ResearchBardstown, United StatesRecruiting
  • LSU Health Shreveport Clinical Trials OfficeShreveport, United StatesRecruiting
  • Ochsner/LSU Health Shreveport - Progressive PediatricsShreveport, United StatesRecruiting
  • Ochsner LSU Health Shreveport Ambulatory Care CenterShreveport, United StatesRecruiting
  • Ochsner/LSU Health Shreveport Academic Medical CenterShreveport, United StatesRecruiting
  • Pediatric Associates of Fall RiverFall River, United StatesNot yet recruiting
  • Boston Children's Health PhysiciansHawthorne, United StatesRecruiting
  • Maria Fareri Children's HospitalValhalla, United StatesRecruiting
  • Senders PediatricsSouth Euclid, United StatesRecruiting
  • Legacy Clinical TrialsOklahoma City, United StatesRecruiting
  • Cyn3rgy Research CorporationGresham, United StatesRecruiting
  • Donald Guthrie FoundationSayre, United StatesNot yet recruiting
  • Guthrie Medical GroupSayre, United StatesNot yet recruiting
  • Tribe Clinical Research LLC. at Parkside Pediatrics Five ForksSimpsonville, United StatesRecruiting
  • Pediatric Research of Charlottesville, LLC.Gordonsville, United StatesRecruiting
  • Perth Children's HospitalNedlands, AustraliaNot yet recruiting
  • The Kids Research Institute AustraliaNedlands, AustraliaNot yet recruiting
  • Milestone Research Inc.London, CanadaNot yet recruiting
  • Bluewater Clinical Research Group Inc.Sarnia, CanadaNot yet recruiting
Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-523447-35-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)