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

NCT05412030 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 2196512023-000423-36
• Study Type: interventional
• Target: 388
• Locations: 2 countries
• Sites: 46

Brief 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

Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal

Keywords

Pneumonia, Pneumococcal; Infections; Streptococcal Infections; Pneumonia

Outcome Measures

Primary Outcomes (4)

• Percentage of participants with solicited injection site events

  The assessed solicited injection site events are tenderness, redness/erythema and swelling.

  Day 1 through Day 7 post-vaccination

• Percentage of participants with solicited systemic events

  The assessed solicited systemic events are irritability, fever, decrease of appetite, increased sleep, and decrease in sleep.

  Day 1 through Day 7 post-vaccination

• Percentage of participants with AEs

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.

  Day 1 through Day 30

• Percentage of participants with serious adverse events (SAEs)

  An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity. Medical or scientific judgment will be exercised by the investigator in deciding whether SAE reporting is appropriate in other situations such as significant medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

  Day 1 through 6 months post dose three

Secondary Outcomes (2)

• Percentage of participants with a pneumococcal serotype-specific Immunoglobulin G (IgG) concentration of greater than or equal to (>=) 0.35 μg/mL or corresponding threshold

  30 days post-dose two, 30 days post-dose three

• Geometric mean concentration for serotype-specific IgG

  30 days post-dose two, 30 days post-dose three

Study Arms (7)

Part 1 Group 1

EXPERIMENTAL

Infants are scheduled to receive up to three doses of 1 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV13 as standard of care (SOC).

Biological: AFX3772; Biological: Prevnar 13

Part 1 Group 2

EXPERIMENTAL

Infants are scheduled to receive up to three doses of 2 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV13 as SOC.

Biological: AFX3772; Biological: Prevnar 13

Part 1 Group 3

EXPERIMENTAL

Infants are scheduled to receive up to three doses of 5 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV13 as SOC.

Biological: AFX3772; Biological: Prevnar 13

Part 1 Group 4

ACTIVE COMPARATOR

PCV13 administered intramuscularly within 12 months.

Biological: Prevnar 13

Part 2 Group 5

EXPERIMENTAL

Infants are scheduled to receive up to three doses of 2 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV20 as SOC.

Biological: AFX3772; Biological: Prevnar 20

Part 2 Group 6

EXPERIMENTAL

Infants are scheduled to receive up to three doses of 5 mcg AFX3772 as part of the primary series, followed by a booster dose. Those who do not receive the planned AFX3772 dose are administered PCV20 as SOC.

Biological: AFX3772; Biological: Prevnar 20

Part 2 Group 7

ACTIVE COMPARATOR

PCV20 administered intramuscularly within 12 months.

Biological: Prevnar 20

Interventions

AFX3772 BIOLOGICAL

AFX3772 administered intramuscularly.

Part 1 Group 1; Part 1 Group 2; Part 1 Group 3; Part 2 Group 5; Part 2 Group 6

Prevnar 13 BIOLOGICAL

PCV13 administered intramuscularly.

Also known as: PCV13

Part 1 Group 1; Part 1 Group 2; Part 1 Group 3; Part 1 Group 4

Prevnar 20 BIOLOGICAL

PCV 20 administered intramuscularly.

Also known as: PCV20

Part 2 Group 5; Part 2 Group 6; Part 2 Group 7

Eligibility Criteria

• Age: 42 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Had prior administration of any pneumococcal vaccine.
• Has a known or suspected hypersensitivity to AFX3772, PCV13, PCV20 or any components of the formulations used.
• Has a known or suspected immunodeficiency or other conditions associated with immunosuppression that may require immunosuppressive drugs. In addition, the participant's biological mother has known HIV infection or known to be hepatitis B surface antigen positive.
• Has any clinically significant allergic condition or history prior to the first vaccination 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 would contraindicate intramuscular injection.
• Has received systemic corticosteroids for a period of more than 14 days and has not completed the treatment for at least 30 days before study vaccine.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (46)

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

GSK Investigational Site

Los Angeles, California, 90057, United States

Location

GSK Investigational Site

Miami, Florida, 33184, United States

Location

GSK Investigational Site

Pensacola, Florida, 32503, United States

Location

GSK Investigational Site

Saint Augustine, Florida, 32086, United States

Location

GSK Investigational Site

Tampa, Florida, 33613, United States

Location

GSK Investigational Site

Nampa, Idaho, 83702, United States

Location

GSK Investigational Site

Bardstown, Kentucky, 40004, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40517, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40291, United States

Location

GSK Investigational Site

Covington, Louisiana, 70433, United States

Location

GSK Investigational Site

Haughton, Louisiana, 71037, United States

Location

GSK Investigational Site

Lafayette, Louisiana, 70508, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70119, United States

Location

GSK Investigational Site

Mankato, Minnesota, 56001, United States

Location

GSK Investigational Site

Missoula, Montana, 59804, United States

Location

GSK Investigational Site

Hastings, Nebraska, 68901, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45245, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74104, United States

Location

GSK Investigational Site

Cranberry Township, Pennsylvania, 16006, United States

Location

GSK Investigational Site

Jefferson Hills, Pennsylvania, 15025, United States

Location

GSK Investigational Site

N. Huntingdon, Pennsylvania, 15642, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15217, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15234, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29407, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29607, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29301, United States

Location

GSK Investigational Site

Brownsville, Texas, 78520, United States

Location

GSK Investigational Site

Dallas, Texas, 75230, United States

Location

GSK Investigational Site

Dickinson, Texas, 77539, United States

Location

GSK Investigational Site

Houston, Texas, 77065, United States

Location

GSK Investigational Site

Houston, Texas, 77077, United States

Location

GSK Investigational Site

Houston, Texas, 77087, United States

Location

GSK Investigational Site

McAllen, Texas, 78504, United States

Location

GSK Investigational Site

Richmond, Texas, 77469, United States

Location

GSK Investigational Site

Layton, Utah, 84041, United States

Location

GSK Investigational Site

Roy, Utah, 84067, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84107, United States

Location

GSK Investigational Site

South Jordan, Utah, 84095, United States

Location

GSK Investigational Site

Syracuse, Utah, 84075, United States

Location

GSK Investigational Site

Norfolk, Virginia, 68701, United States

Location

GSK Investigational Site

Bayamón, 960, Puerto Rico

Location

GSK Investigational Site

Caguas, 00725, Puerto Rico

Location

GSK Investigational Site

Ponce, 00716, Puerto Rico

Location

GSK Investigational Site

San Juan, 00935-6528, Puerto Rico

Location

MeSH Terms

Conditions

Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal; Infections; Streptococcal Infections; Pneumonia

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Gram-Positive Bacterial Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 9, 2022
• Study Start: June 16, 2022
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (42); PR (4)