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New vaccine AFX3772 aims to shield infants from pneumonia

NCT ID NCT05412030

Prevention Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new vaccine called AFX3772 in healthy infants about 2 months old. The goal was to see if it is safe and triggers a strong immune response against pneumococcal bacteria, which can cause pneumonia and other serious infections. Researchers compared AFX3772 with existing vaccines (Prevnar 13 and Prevnar 20) to find the best dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AFX3772 (a pneumococcal vaccine)
What this could lead to
If successful, this could lead to a new vaccine option to protect infants against pneumococcal diseases like pneumonia.
What could go wrong
This is an early Phase 2 trial with only 388 infants, so results may not confirm effectiveness or safety in larger populations. Different vaccine formulations are being tested, and some may not work as well as existing vaccines.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

388 people

The number who actually took part.

Started

Jun 2022

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

42 to 90 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: • Is a full-term infant approximately 2 months of age at time of obtaining the informed consent. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

bacterial pneumonia Infections pneumonia streptococcal infection streptococcal pneumonia pneumococcal infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pneumococcal infections Pneumonia - bacterial Pneumonia, pneumococcal

Contacts and locations

Locations

  • GSK Investigational Site

    Miami, Florida, 33184, United States

  • GSK Investigational Site

    Pensacola, Florida, 32503, United States

  • GSK Investigational Site

    Saint Augustine, Florida, 32086, United States

  • GSK Investigational Site

    Tampa, Florida, 33613, United States

  • GSK Investigational Site

    Nampa, Idaho, 83702, United States

  • GSK Investigational Site

    Bardstown, Kentucky, 40004, United States

  • GSK Investigational Site

    Lexington, Kentucky, 40517, United States

  • GSK Investigational Site

    Louisville, Kentucky, 40291, United States

  • GSK Investigational Site

    Covington, Louisiana, 70433, United States

  • GSK Investigational Site

    Haughton, Louisiana, 71037, United States

  • GSK Investigational Site

    Lafayette, Louisiana, 70508, United States

  • GSK Investigational Site

    New Orleans, Louisiana, 70119, United States

  • GSK Investigational Site

    Mankato, Minnesota, 56001, United States

  • GSK Investigational Site

    Missoula, Montana, 59804, United States

  • GSK Investigational Site

    Hastings, Nebraska, 68901, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45245, United States

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104, United States

  • GSK Investigational Site

    Cranberry Township, Pennsylvania, 16006, United States

  • GSK Investigational Site

    Jefferson Hills, Pennsylvania, 15025, United States

  • GSK Investigational Site

    N. Huntingdon, Pennsylvania, 15642, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15217, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15234, United States

  • GSK Investigational Site

    Charleston, South Carolina, 29407, United States

  • GSK Investigational Site

    Greenville, South Carolina, 29607, United States

  • GSK Investigational Site

    Spartanburg, South Carolina, 29301, United States

  • GSK Investigational Site

    Brownsville, Texas, 78520, United States

  • GSK Investigational Site

    Dallas, Texas, 75230, United States

  • GSK Investigational Site

    Dickinson, Texas, 77539, United States

  • GSK Investigational Site

    Houston, Texas, 77065, United States

  • GSK Investigational Site

    Houston, Texas, 77077, United States

  • GSK Investigational Site

    Houston, Texas, 77087, United States

  • GSK Investigational Site

    McAllen, Texas, 78504, United States

  • GSK Investigational Site

    Richmond, Texas, 77469, United States

  • GSK Investigational Site

    Layton, Utah, 84041, United States

  • GSK Investigational Site

    Roy, Utah, 84067, United States

  • GSK Investigational Site

    Salt Lake City, Utah, 84107, United States

  • GSK Investigational Site

    South Jordan, Utah, 84095, United States

  • GSK Investigational Site

    Syracuse, Utah, 84075, United States

  • GSK Investigational Site

    Norfolk, Virginia, 68701, United States

  • GSK Investigational Site

    Bayamón, 960, Puerto Rico

  • GSK Investigational Site

    Caguas, 00725, Puerto Rico

  • GSK Investigational Site

    Ponce, 00716, Puerto Rico

  • GSK Investigational Site

    San Juan, 00935-6528, Puerto Rico

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401, United States

  • GSK Investigational Site

    Los Angeles, California, 90057, United States

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