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Pneumonia, BacterialPhase 2NCT05412030

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

A Phase 2 study testing AFX3772, Prevnar 13 and Prevnar 20 in people with Pneumonia, Bacterial and Pneumococcal Infections, run by GlaxoSmithKline at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 42 to 90 daysHealthy volunteers can take part
What is being tested?
AFX3772, Prevnar 13 and Prevnar 20
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
388 participants
Where
52 sitesin 2 countries
Study dates
16 Jun 2022to 18 Sep 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 42 to 90 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Participant has an LAR who understands study procedures, alternative treatments and risks involved in the study and who voluntarily agrees to participate by giving informed consent.
  • Participant is a full-term (≥37 weeks gestation at birth) infant approximately 2 months of age (42 to 90 days, inclusive) at time of obtaining the informed consent.
  • Participant is healthy based on the clinical judgment of the investigator following review of medical history and physical examination.

Who cannot join

  • Participant had prior administration of any pneumococcal vaccine.
  • Participant has a known or suspected hypersensitivity to AFX3772, PCV13, PCV20 or any components of the formulations used.
  • Participant has a known or suspected immunodeficiency (including autoimmune disease) or other conditions associated with immunosuppression that may require immunosuppressive drugs including but not limited to HIV infection, malignancy or organ or bone marrow transplant.
  • In addition, the participant's biological mother has known HIV infection or known to be hepatitis B surface antigen positive.
  • Participant has any clinically significant allergic condition or history (including anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to the first vaccination for primary immunization series.
  • Participant has functional asplenia.
Show all 20Show fewer
  • Participant has medical history of epilepsy or febrile convulsion.
  • Participant weighed <2000 g at birth.
  • Participant has known neurological or cognitive behavioral disorders including clinically significant developmental disorder and related disorders.
  • Participant has any active malignancy or history of malignancy.
  • Participant has a history of microbiologically proven invasive disease caused by S. pneumoniae.
  • Participant has cochlear implant or cerebrospinal fluid leakage.
  • Has received other licensed non-live vaccines within the 14 days or a licensed live virus vaccine within the 30 days prior to receipt of study vaccine.
  • Participant has received immunoglobulins. Note: This does not include monoclonal antibodies, such as palivizumab or nirsevimab.
  • Participant has a bleeding diathesis or condition associated with prolonged bleeding that would contraindicate intramuscular injection.
  • Participant has received systemic corticosteroids (equivalent of >2 mg/kg total daily dose of prednisone or >20 mg/day for persons weighing >10 kg) for a period of more than 14 days and has not completed the treatment for at least 30 days before study vaccine. Topical, ophthalmic, and inhaled steroids are allowed.
  • Participant has febrile illness (rectal temperature ≥38.1°C [100.5°F] or axillary temperature ≥37.8°C [100.0°F]) in Part 1 and Part 2 prior to the effective date of protocol amendment 4. After protocol amendment 4 becomes effective, febrile illness is defined as rectal temperature ≥38.0°C [100.4°F] or axillary temperature ≥37.5°C (99.1°F) in Part 2. Upon resolution of symptoms, participant can be rescreened.
  • Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • Participant has any condition which, in the investigator's opinion, makes the participant unsuitable for study participation.
  • LARs that are study personnel or their immediate dependents, family, or household members.

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

United States48 sites

  • GSK Investigational Site

    Bardstown, Kentucky, 40004

  • GSK Investigational Site

    Brownsville, Texas, 78520

  • GSK Investigational Site

    Charleston, South Carolina, 29407-4726

  • GSK Investigational Site

    Cincinnati, Ohio, 45245

  • GSK Investigational Site

    Cleveland, Ohio, 44121

  • GSK Investigational Site

    Covington, Louisiana, 70433

  • GSK Investigational Site

    Cranberry Township, Pennsylvania, 16006

  • GSK Investigational Site

    Dallas, Texas, 75230-2501

  • GSK Investigational Site

    Dickinson, Texas, 77539

  • GSK Investigational Site

    Gardena, California, 90247

  • GSK Investigational Site

    Greenville, South Carolina, 29607

  • GSK Investigational Site

    Hastings, Nebraska, 68901

  • GSK Investigational Site

    Haughton, Louisiana, 71037

  • GSK Investigational Site

    Houston, Texas, 77065-5470

  • GSK Investigational Site

    Houston, Texas, 77071

  • GSK Investigational Site

    Houston, Texas, 77077

  • GSK Investigational Site

    Houston, Texas, 77087-1122

  • GSK Investigational Site

    Jefferson Hills, Pennsylvania, 15025

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Lafayette, Louisiana, 70508

  • GSK Investigational Site

    Layton, Utah, 84041

  • GSK Investigational Site

    Lexington, Kentucky, 40517

  • GSK Investigational Site

    Los Angeles, California, 90057

  • GSK Investigational Site

    Louisville, Kentucky, 40291

  • GSK Investigational Site

    Madera, California, 93637

  • GSK Investigational Site

    Mankato, Minnesota, 56001

  • GSK Investigational Site

    McAllen, Texas, 78504

  • GSK Investigational Site

    Miami, Florida, 33184

  • GSK Investigational Site

    Missoula, Montana, 59804

  • GSK Investigational Site

    N. Huntingdon, Pennsylvania, 15642

  • GSK Investigational Site

    Nampa, Idaho, 83702

  • GSK Investigational Site

    New Orleans, Louisiana, 70119-7100

  • GSK Investigational Site

    Norfolk, Nebraska, 68701-7701

  • GSK Investigational Site

    Ontario, California, 91762

  • GSK Investigational Site

    Pensacola, Florida, 32503

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213-3205

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15217-1212

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15234

  • GSK Investigational Site

    Richmond, Texas, 77469

  • GSK Investigational Site

    Roy, Utah, 84067

  • GSK Investigational Site

    Saint Augustine, Florida, 32086-5774

  • GSK Investigational Site

    Salt Lake City, Utah, 84107

  • GSK Investigational Site

    South Jordan, Utah, 84095-3211

  • GSK Investigational Site

    Spartanburg, South Carolina, 29301

  • GSK Investigational Site

    Syracuse, Utah, 84075-9645

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    Tampa, Florida, 33617

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104

Other trials in United States

Puerto Rico4 sites

  • GSK Investigational Site

    Bayamón, 960

  • GSK Investigational Site

    Caguas, 00725

  • GSK Investigational Site

    Ponce, 00716-0377

  • GSK Investigational Site

    San Juan, 00935-6528

Other trials in Puerto Rico

About this study

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

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.

Read more

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.

Being tested
AFX3772, Prevnar 13, Prevnar 20
Keywords
Pneumonia, Pneumococcal, Infections, Streptococcal Infections, Pneumonia
Medical subject headings
Pneumonia, Bacterial, Pneumococcal Infections, Pneumonia, Pneumococcal, Infections, Streptococcal Infections, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AFX3772Biological

    AFX3772 administered intramuscularly.

  • Prevnar 13Biological

    Also called PCV13

    PCV13 administered intramuscularly.

  • Prevnar 20Biological

    Also called PCV20

    PCV 20 administered intramuscularly.

Study groups in NCT05412030
Study groupRoleWhat they receive
Part 1: AFX3772 1 µgExperimentalAFX3772 1 µg was administered at 2, 4, and 6 months of age. Participants who did not receive a planned AFX3772 dose received PCV13 as standard of care.
Receives: Biological: AFX3772; Biological: Prevnar 13
Part 1: AFX3772 2 µgExperimentalAFX3772 2 µg was administered at 2, 4, and 6 months of age. Participants who did not receive a planned AFX3772 dose received PCV13 as standard of care.
Receives: Biological: AFX3772; Biological: Prevnar 13
Part 1: AFX3772 5 µgExperimentalAFX3772 5 µg was administered at 2, 4, and 6 months of age. Participants who did not receive a planned AFX3772 dose received PCV13 as standard of care.
Receives: Biological: AFX3772; Biological: Prevnar 13
Part 1 Comparator: PCV13Active comparatorPCV13 was administered at 2, 4, and 6 months of age.
Receives: Biological: Prevnar 13
Part 2: AFX3772 2 µgExperimentalAFX3772 2 µg was administered at 2, 4, and 6 months of age. Participants who did not receive a planned AFX3772 dose received PCV20 as standard of care.
Receives: Biological: AFX3772; Biological: Prevnar 20
Part 2: AFX3772 5 µgExperimentalFX3772 5 µg was administered at 2, 4, and 6 months of age. Participants who did not receive a planned AFX3772 dose received PCV20 as standard of care.
Receives: Biological: AFX3772; Biological: Prevnar 20
Part 2 Comparator: PCV20Active comparatorPCV20 was administered at 2, 4, and 6 months of age.
Receives: Biological: Prevnar 20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting Any Solicited Injection Site Adverse Events (AEs) After First Dose

    The assessed solicited injection site events were pain/tenderness, redness/erythema and swelling/induration. Any = occurrence of the event regardless of the intensity grade.

    Measured: Day 1 to Day 7 post dose 1

  2. Number of Participants Reporting Any Solicited Injection Site AEs After Second Dose

    Measured: Day 1 to Day 7 post dose 2

  3. Number of Participants Reporting Any Solicited Injection Site AEs After Third Dose

    Measured: Day 1 to Day 7 post dose 3

  4. Number of Participants Reporting Any Solicited Systemic Events After First Dose

    The assessed solicited systemic events are irritability, fever, appetite loss, increased sleep, and decrease in sleep. Any = occurrence of the event regardless of the intensity grade.

    Measured: Day 1 to Day 7 post dose 1

  5. Number of Participants Reporting Any Solicited Systemic Events After Second Dose

    Measured: Day 1 to Day 7 post dose 2

  6. Number of Participants Reporting Any Solicited Systemic Events After Third Dose

    Measured: Day 1 to Day 7 post dose 3

  7. Number of Participants Reporting Any Unsolicited AEs

    An unsolicited AE was defined as any adverse event that was not actively solicited through the participant eDiary and was reported by the participant's legally authorized representative (LAR) or identified by site personnel. Unsolicited AEs included both serious and non-serious AEs. Any = occurrence of the event regardless of the intensity grade.

    Measured: Within 30 days post each dose (at 2, 4, and 6 months of age as part of primary vaccination series)

  8. Number of Participants Reporting Any 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.

    Measured: Day 1 through 6 months post dose 3

Secondary outcomes (2)

  1. Proportion of Participants With a Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentration of >= 0.35 μg/mL

    Immunogenicity data has not been presented since no participants completed the planned 3+1 vaccination regimen with the investigational vaccine and instead received standard-of-care pneumococcal vaccination.

    Measured: 30 days post-dose 2 and 3

  2. Geometric Mean Concentration (GMC) for Serotype-specific IgG

    Immunogenicity data has not been presented since no participants completed the planned 3+1 vaccination regimen with the investigational vaccine and instead received standard-of-care pneumococcal vaccination.

    Measured: 30 days post-dose 2 and 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start16 Jun 2022
  3. Primary completion18 Sep 2025
  4. Study completion18 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05412030
Sponsor's protocol ID
219651
Other IDs
2023-000423-36, 2023
Status last verified
Sep 2026
First submitted
3 Jun 2022
Last updated
9 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AFX3772, Prevnar 13 and Prevnar 20 in people with Pneumonia, Bacterial and Pneumococcal Infections, run by GlaxoSmithKline at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Any Solicited Injection Site Adverse Events (AEs) After First Dose (time frame: Day 1 to Day 7 post dose 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05412030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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