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COMPLETED
NCT05412030
PHASE2

A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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

BIOLOGICAL

AFX3772

AFX3772 administered intramuscularly.

BIOLOGICAL

Prevnar 13

PCV13 administered intramuscularly.

BIOLOGICAL

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