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NCT07629440 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
A Phase 3 study, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 3,230
- Enrollment target
NCT07629440 is a Phase 3 study that is actively recruiting participants, run by Pfizer. The registered enrollment target is 3,230 participants.
The verdict
NCT07629440, a Phase 3 study, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 3,230 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. It will also assess how the new vaccine works in comparison to the one that is currently in use when given with other childhood vaccines. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. 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 three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are: * infants who are 2 months of age in Group 1; * infants who are 2 to 6 months of age in Groups 2 and 3; and * said to be healthy by the study doctor About 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving 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. About 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. About 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving eit
Interventions
- BIOLOGICAL PG4
- BIOLOGICAL 20-valent pneumococcal conjugate vaccine (20vPnC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,230 participants |
| Start Date | 2026-05-29 |
| Est. Completion | 2029-06-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07629440
The ClinicalTrials.gov registry entry for NCT07629440 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 3,230 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.
NCT07629440 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07629440 about?
NCT07629440 is a clinical study titled "A Study to Learn About How a New Pneumococcal Vaccine Works in 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 NCT07629440?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 3,230 participants. The study started on 2026-05-29. Estimated completion is 2029-06-05.
What interventions are being tested in trial NCT07629440?
The interventions under investigation include: PG4 (BIOLOGICAL), 20-valent pneumococcal conjugate vaccine (20vPnC) (BIOLOGICAL).
Who is sponsoring clinical trial NCT07629440?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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