Trials / Completed
CompletedNCT05412030
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
A Phase 2, Randomized, Double-blind, Multi-dose, Dose Finding Study to Evaluate the Safety, Tolerability and Immunogenicity of AFX3772 Compared With PCVs in Healthy Infants
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 388 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 42 Days – 90 Days
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AFX3772 | AFX3772 administered intramuscularly. |
| BIOLOGICAL | Prevnar 13 | PCV13 administered intramuscularly. |
| BIOLOGICAL | Prevnar 20 | PCV 20 administered intramuscularly. |
Timeline
- Start date
- 2022-06-16
- Primary completion
- 2025-09-18
- Completion
- 2025-09-18
- First posted
- 2022-06-09
- Last updated
- 2025-10-21
Locations
46 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05412030. Inclusion in this directory is not an endorsement.