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NCT05412030 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 388
- Enrollment target
NCT05412030: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT05412030 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 388 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (192% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05412030, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 388 participants
- Enrollment target
Study Summary
This is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different formulations of AFX3772 compared with Prevnar 13 (PCV13) and Prevnar 20 (PCV). Part 1 is the dose escalation, lead-in portion of the study in which infants at each dose level will be randomized 3:1 in sequential cohorts of increasing doses of AFX3772 or PCV13. In Part 2, infants will be randomized to receive either one of two dose levels of AFX3772 or PCV20.
Primary Outcome
The assessed solicited injection site events are tenderness, redness/erythema and swelling.
Interventions
- BIOLOGICAL Prevnar 13
- BIOLOGICAL AFX3772
- BIOLOGICAL Prevnar 20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2022-06-16 |
| Est. Completion | 2025-09-18 |
| Phase | Phase 2 |
What the finished NCT05412030 record still lists
NCT05412030 is an interventional study that assigns participants to a tested intervention. The registered 388 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (192% higher).
The record links to 0 conditions, and to 3 interventions - of which Prevnar 13 is the first listed.
NCT05412030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05412030 about?
NCT05412030 is a clinical study titled "A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants". This is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different formulations of AFX3772 compared with Prevnar 13 (PCV13) and Prevnar 20 ...
What is the current status of trial NCT05412030?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 388 participants. The study started on 2022-06-16. Estimated completion is 2025-09-18.
What interventions are being tested in trial NCT05412030?
The interventions under investigation include: Prevnar 13 (BIOLOGICAL), AFX3772 (BIOLOGICAL), Prevnar 20 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05412030?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05412030's enrollment target sits among peer trials
388 109th of 2000 higher than 1,892 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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