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A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
Sponsor: GlaxoSmithKline
Summary
This is a Phase 2 clinical study evaluating AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of three different formulations of AFX3772 compared with Prevnar 13 (PCV13) and Prevnar 20 (PCV20). Part 1 is the dose-escalation lead-in portion of the study, in which infants at each dose level are randomized 3:1 in sequential cohorts to receive increasing doses of AFX3772 or PCV13. In Part 2, infants are randomized to receive either one of two dose levels of AFX3772 or PCV20. On 31 October 2024, the study was placed on partial clinical hold by the U.S. Food and Drug Administration. The hold was not related to safety concerns in participants who had already received the study vaccines. As a result, enrollment was paused and no further doses of the investigational pneumococcal vaccine were administered. Participants who were already enrolled transitioned to the standard of care pneumococcal vaccine to complete their scheduled visits through post-dose 3 and subsequently completed study follow-up.
Official title: 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
Key Details
Gender
All
Age Range
42 Days - 90 Days
Study Type
INTERVENTIONAL
Enrollment
388
Start Date
2022-06-16
Completion Date
2025-09-18
Last Updated
2026-10-09
Healthy Volunteers
Yes
Interventions
AFX3772
AFX3772 administered intramuscularly.
Prevnar 13
PCV13 administered intramuscularly.
Prevnar 20
PCV 20 administered intramuscularly.
Locations (52)
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Gardena, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Madera, California, United States
GSK Investigational Site
Ontario, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Pensacola, Florida, United States
GSK Investigational Site
Saint Augustine, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Covington, Louisiana, United States
GSK Investigational Site
Haughton, Louisiana, United States
GSK Investigational Site
Lafayette, Louisiana, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Mankato, Minnesota, United States
GSK Investigational Site
Missoula, Montana, United States
GSK Investigational Site
Hastings, Nebraska, United States
GSK Investigational Site
Norfolk, Nebraska, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Tulsa, Oklahoma, United States
GSK Investigational Site
Cranberry Township, Pennsylvania, United States
GSK Investigational Site
Jefferson Hills, Pennsylvania, United States
GSK Investigational Site
N. Huntingdon, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Greenville, South Carolina, United States
GSK Investigational Site
Spartanburg, South Carolina, United States
GSK Investigational Site
Brownsville, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Dickinson, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
McAllen, Texas, United States
GSK Investigational Site
Richmond, Texas, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Roy, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
South Jordan, Utah, United States
GSK Investigational Site
Syracuse, Utah, United States
GSK Investigational Site
Bayamón, Puerto Rico
GSK Investigational Site
Caguas, Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico
GSK Investigational Site
San Juan, Puerto Rico