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

Last updated: October 17, 2025
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

2

Condition

Pneumonia

Pressure Ulcers

Pneumococcal Disease

Treatment

AFX3772

Prevnar 20

Prevnar 13

Clinical Study ID

NCT05412030
219651
AFX3772-003
2023-000423-36
  • Ages 42-90
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

• Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.

Exclusion

Exclusion Criteria:

  • Had prior administration of any pneumococcal vaccine.

  • Has a known or suspected hypersensitivity to AFX3772, PCV13, PCV20 or any componentsof the formulations used.

  • Has a known or suspected immunodeficiency or other conditions associated withimmunosuppression that may require immunosuppressive drugs. In addition, theparticipant's biological mother has known HIV infection or known to be hepatitis Bsurface antigen positive.

  • Has any clinically significant allergic condition or history prior to the firstvaccination for primary immunization series.

  • Has a history of microbiologically proven invasive disease caused by S. pneumoniae.

  • Has received immunoglobulins.

  • Has a bleeding diathesis or condition associated with prolonged bleeding that wouldcontraindicate intramuscular injection.

  • Has received systemic corticosteroids for a period of more than 14 days and has notcompleted the treatment for at least 30 days before study vaccine.

Study Design

Total Participants: 388
Treatment Group(s): 3
Primary Treatment: AFX3772
Phase: 2
Study Start date:
June 16, 2022
Estimated Completion Date:
September 18, 2025

Connect with a study center

  • GSK Investigational Site

    Bayamón 4562831, 960
    Puerto Rico

    Site Not Available

  • GSK Investigational Site

    Caguas 4563008, 00725
    Puerto Rico

    Site Not Available

  • GSK Investigational Site

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • GSK Investigational Site

    Ponce 4566880, 00716
    Puerto Rico

    Site Not Available

  • GSK Investigational Site

    San Juan, 00935-6528
    Puerto Rico

    Site Not Available

  • GSK Investigational Site

    San Juan 4568127, 00935-6528
    Puerto Rico

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • GSK Investigational Site

    Tucson, Arizona 85745
    United States

    Site Not Available

  • GSK Investigational Site

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • The Children's Clinic of Jonesboro, P.A.

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • GSK Investigational Site

    Jonesboro 4116834, Arkansas 4099753 72401
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 90057
    United States

    Site Not Available

  • Madera Family Medical Group

    Madera, California 93637
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles 5368361, California 5332921 90057
    United States

    Site Not Available

  • GSK Investigational Site

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Bio-Medical Research, LLC

    Miami, Florida 33184
    United States

    Site Not Available

  • GSK Investigational Site

    Pensacola, Florida 32503
    United States

    Site Not Available

  • SEC Clinical Research

    Pensacola, Florida 32501
    United States

    Site Not Available

  • St. John's Center for Clinical Research

    Saint Augustine, Florida 32086
    United States

    Site Not Available

  • GSK Investigational Site

    Tampa, Florida 33613
    United States

    Site Not Available

  • GSK Investigational Site

    Miami 4164138, Florida 4155751 33184
    United States

    Site Not Available

  • GSK Investigational Site

    Pensacola 4168228, Florida 4155751 32503
    United States

    Site Not Available

  • GSK Investigational Site

    Saint Augustine 4170894, Florida 4155751 32086
    United States

    Site Not Available

  • GSK Investigational Site

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • Tekton Research

    Chamblee, Georgia 30341
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Macon, Georgia 31210
    United States

    Site Not Available

  • GSK Investigational Site

    Nampa, Idaho 83687
    United States

    Site Not Available

  • GSK Investigational Site

    Nampa 5601933, Idaho 5596512 83702
    United States

    Site Not Available

  • GSK Investigational Site

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • GSK Investigational Site

    Bardstown, Kentucky 40004
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington, Kentucky 40517
    United States

    Site Not Available

  • GSK Investigational Site

    Louisville, Kentucky 40291
    United States

    Site Not Available

  • GSK Investigational Site

    Bardstown 4283133, Kentucky 6254925 40004
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington 4297983, Kentucky 6254925 40517
    United States

    Site Not Available

  • GSK Investigational Site

    Louisville 4299276, Kentucky 6254925 40291
    United States

    Site Not Available

  • GSK Investigational Site

    Haughton, Louisiana 71037
    United States

    Site Not Available

  • GSK Investigational Site

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • MedPharmcis, LLC

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • GSK Investigational Site

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • GSK Investigational Site

    Covington 4321005, Louisiana 4331987 70433
    United States

    Site Not Available

  • GSK Investigational Site

    Haughton 4327084, Louisiana 4331987 71037
    United States

    Site Not Available

  • GSK Investigational Site

    Lafayette 4330145, Louisiana 4331987 70508
    United States

    Site Not Available

  • GSK Investigational Site

    New Orleans 4335045, Louisiana 4331987 70119
    United States

    Site Not Available

  • Mankato Clinic

    Mankato, Minnesota 56001
    United States

    Site Not Available

  • GSK Investigational Site

    Mankato 5036420, Minnesota 5037779 56001
    United States

    Site Not Available

  • Boeson Research

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Boeson Research

    Missoula, Montana 59804
    United States

    Site Not Available

  • GSK Investigational Site

    Missoula, Montana 59804
    United States

    Site Not Available

  • GSK Investigational Site

    Missoula 5666639, Montana 5667009 59804
    United States

    Site Not Available

  • GSK Investigational Site

    Hastings, Nebraska 68901
    United States

    Site Not Available

  • Meridian Clinical Research

    Hastings, Nebraska 68901
    United States

    Site Not Available

  • GSK Investigational Site

    Hastings 5069802, Nebraska 5073708 68901
    United States

    Site Not Available

  • Senders Pediatrics

    South Euclid, Ohio 44121
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati 4508722, Ohio 5165418 45245
    United States

    Site Not Available

  • GSK Investigational Site

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Oklahoma State University- Center for Health Sciences

    Tulsa, Oklahoma 74127
    United States

    Site Not Available

  • GSK Investigational Site

    Tulsa 4553433, Oklahoma 4544379 74104
    United States

    Site Not Available

  • Cyn3rgy Research

    Gresham, Oregon 97030
    United States

    Site Not Available

  • GSK Investigational Site

    Cranberry Township 8643098, Pennsylvania 6254927 16006
    United States

    Site Not Available

  • GSK Investigational Site

    Jefferson Hills 5195297, Pennsylvania 6254927 15025
    United States

    Site Not Available

  • GSK Investigational Site

    N. Huntingdon, Pennsylvania 6254927 15642
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh 5206379, Pennsylvania 6254927 15217
    United States

    Site Not Available

  • Meridian Clinical Research

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Tribe Clinical Research LLC

    Greenville, South Carolina 29609
    United States

    Site Not Available

  • GSK Investigational Site

    Spartanburg, South Carolina 29301
    United States

    Site Not Available

  • Tribe Clinical Research

    Spartanburg, South Carolina 29301
    United States

    Site Not Available

  • GSK Investigational Site

    Charleston 4574324, South Carolina 4597040 29407
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville 4580543, South Carolina 4597040 29607
    United States

    Site Not Available

  • GSK Investigational Site

    Spartanburg 4597200, South Carolina 4597040 29301
    United States

    Site Not Available

  • Pan American Clinical Research

    Brownsville, Texas 78520
    United States

    Site Not Available

  • Forest Lane Pediatrics, LLC

    Dallas, Texas 75230
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • Bay Colony Pediatrics

    Dickinson, Texas 77539
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77065
    United States

    Site Not Available

  • Houston Clinical Research Associates

    Houston, Texas 77090
    United States

    Site Not Available

  • Kool Kids Pediatrics

    Houston, Texas 77065
    United States

    Site Not Available

  • Pediatric Associates

    Houston, Texas 77087
    United States

    Site Not Available

  • Kingsland Pediatrics

    Katy, Texas 77450
    United States

    Site Not Available

  • Pediatric Center

    Richmond, Texas 77469
    United States

    Site Not Available

  • Tekton Research

    San Antonio, Texas 78244
    United States

    Site Not Available

  • GSK Investigational Site

    Brownsville 4676740, Texas 4736286 78520
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • GSK Investigational Site

    Dickinson 4686163, Texas 4736286 77539
    United States

    Site Not Available

  • GSK Investigational Site

    Houston 4699066, Texas 4736286 77065
    United States

    Site Not Available

  • GSK Investigational Site

    McAllen 4709796, Texas 4736286 78504
    United States

    Site Not Available

  • GSK Investigational Site

    Richmond 4722684, Texas 4736286 77469
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Layton, Utah 84041
    United States

    Site Not Available

  • GSK Investigational Site

    Layton, Utah 84041
    United States

    Site Not Available

  • GSK Investigational Site

    Roy, Utah 84067
    United States

    Site Not Available

  • Wee Care Pediatric

    Roy, Utah 84067
    United States

    Site Not Available

  • Cottonwood Pediatrics

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • GSK Investigational Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • GSK Investigational Site

    South Jordan, Utah 84095
    United States

    Site Not Available

  • Intermountain River Hospital

    South Jordan, Utah 84095
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Syracuse, Utah 84075
    United States

    Site Not Available

  • GSK Investigational Site

    Layton 5777107, Utah 5549030 84041
    United States

    Site Not Available

  • GSK Investigational Site

    Roy 5780802, Utah 5549030 84067
    United States

    Site Not Available

  • GSK Investigational Site

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Site Not Available

  • GSK Investigational Site

    South Jordan 5781770, Utah 5549030 84095
    United States

    Site Not Available

  • GSK Investigational Site

    Syracuse 5782391, Utah 5549030 84075
    United States

    Site Not Available

  • GSK Investigational Site

    Norfolk 4776222, Virginia 6254928 68701
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.