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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: Recruiting Phase 3 study, sponsored by Pfizer.

NCT07573462 is a Phase 3 study that is actively recruiting participants, run by Pfizer. The registered enrollment target is 2,400 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (211% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Prompted local reactions after each dose

Interventions

  • BIOLOGICAL PG4
  • BIOLOGICAL 20-valent pneumococcal conjugate vaccine (20vPnC)

Trial Details

FieldValue
Enrollment Target 2,400 participants
Start Date 2026-05-04
Est. Completion 2028-12-30
Phase Phase 3
Pfizer

1,845 total trials

What NCT07573462 shows while recruiting

NCT07573462 is an interventional study that assigns participants to a tested intervention. Its 2,400 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (211% higher).

The record links to 0 conditions, and to 2 interventions - of which PG4 is the first listed.

NCT07573462 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT07573462's enrollment target sits among peer trials

2,400 89th of 2000 higher than 1,910 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07573462, the US trial registry maintained by the National Library of Medicine. NCT07573462 (large enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.