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

NCT07573462 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: C49310072025-523447-35-00
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (5)

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

  Prompted local reactions after each dose

  Day 7

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

  Prompted systemic events after each dose

  Day 7

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

  AEs occurring from Dose 1 to 1 month after Dose 3

  Dose 1 to 1 month after Dose 3

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

  AEs occurring from Dose 4 to 1 month after Dose 4

  Dose 4 to 1 month after Dose 4

• Percentage of participants reporting serious adverse events (SAEs)

  SAEs occurring from Dose 1 to 6 months after Dose 4

  Dose 1 to 6 months after Dose 4

Study Arms (2)

PG4 (intramuscular)

EXPERIMENTAL

Multivalent Pneumococcal Vaccine

Biological: PG4

20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)

ACTIVE COMPARATOR

20-valent pneumococcal conjugate vaccine (20vPnC)

Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)

Interventions

PG4 BIOLOGICAL

Multivalent Pneumococcal Vaccine

PG4 (intramuscular)

20-valent pneumococcal conjugate vaccine (20vPnC) BIOLOGICAL

20-valent pneumococcal conjugate vaccine (20vPnC)

Also known as: Prevnar 20

20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Starz Pediatrics

Estero, Florida, 33928, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks

Simpsonville, South Carolina, 29680, United States

Location

Pediatric Research of Charlottesville, LLC

Gordonsville, Virginia, 22942, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): May 21, 2026
• Primary Completion (Estimated): January 28, 2029
• Study Completion (Estimated): January 28, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)