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NCT07573462 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
A Phase 3 study, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 2,400
- Enrollment target
NCT07573462 is a Phase 3 study that is actively recruiting participants, run by Pfizer. The registered enrollment target is 2,400 participants.
The verdict
NCT07573462, a Phase 3 study, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,400 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL PG4
- BIOLOGICAL 20-valent pneumococcal conjugate vaccine (20vPnC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,400 participants |
| Start Date | 2026-05-04 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07573462
The ClinicalTrials.gov registry entry for NCT07573462 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 2,400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PG4 is the first listed.
NCT07573462 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07573462 about?
NCT07573462 is a clinical study titled "A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants". 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 pneumoco...
What is the current status of trial NCT07573462?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 2,400 participants. The study started on 2026-05-04. Estimated completion is 2028-12-30.
What interventions are being tested in trial NCT07573462?
The interventions under investigation include: PG4 (BIOLOGICAL), 20-valent pneumococcal conjugate vaccine (20vPnC) (BIOLOGICAL).
Who is sponsoring clinical trial NCT07573462?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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