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.
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
- Conditions the study is for
- Pneumonia, Bacterial, Pneumococcal Infections, Pneumonia, Pneumococcal
- 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
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
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
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 group | Role | What they receive |
|---|---|---|
| Part 1: AFX3772 1 µg | Experimental | AFX3772 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 µg | Experimental | AFX3772 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 µg | Experimental | AFX3772 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: PCV13 | Active comparator | PCV13 was administered at 2, 4, and 6 months of age. Receives: Biological: Prevnar 13 |
| Part 2: AFX3772 2 µg | Experimental | AFX3772 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 µg | Experimental | FX3772 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: PCV20 | Active comparator | PCV20 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.
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
Number of Participants Reporting Any Solicited Injection Site AEs After Second Dose
Measured: Day 1 to Day 7 post dose 2
Number of Participants Reporting Any Solicited Injection Site AEs After Third Dose
Measured: Day 1 to Day 7 post dose 3
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
Number of Participants Reporting Any Solicited Systemic Events After Second Dose
Measured: Day 1 to Day 7 post dose 2
Number of Participants Reporting Any Solicited Systemic Events After Third Dose
Measured: Day 1 to Day 7 post dose 3
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)
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)
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
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.
- First posted9 Jun 2022
- Study start16 Jun 2022
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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