Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AFX3772 · 1 trial · 3 indications
The assessed solicited injection site events were pain/tenderness, redness/erythema and swelling/induration. Any = occurrence of the event regardless of the intensity grade.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Part 1 Comparator: PCV13 | ACTIVE_COMPARATOR | PCV13 was administered at 2, 4, and 6 months of age. |
| 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. |
| 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. |
| Part 2 Comparator: PCV20 | ACTIVE_COMPARATOR | PCV20 was administered at 2, 4, and 6 months of age. |
| Name | Type | Description |
|---|---|---|
| AFX3772 | BIOLOGICAL | AFX3772 administered intramuscularly. |
| Prevnar 13 | BIOLOGICAL | PCV13 administered intramuscularly. |
| Prevnar 20 | BIOLOGICAL | PCV 20 administered intramuscularly. |
Inclusion Criteria: 1. 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. 2. Participant is a full-term (≥37 weeks gestation at birth) infant approximately 2 months of ...
AFX3772 is an investigational monoclonal antibody being developed for bacterial pneumonia and pneumococcal infections. It is being studied as a vaccine to evaluate safety, tolerability, and immune response in healthy infants. The drug is in Phase 2 clinical development and is not yet approved.
AFX3772 is being developed by GSK plc, a biopharmaceutical company traded on the New York Stock Exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety, tolerability, and immune response of AFX3772 in healthy infants.
AFX3772 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 study has been completed, and the drug remains under investigation for bacterial pneumonia and pneumococcal infections.
AFX3772 has one completed Phase 2 clinical trial, identified as NCT05412030. This study evaluated the safety, tolerability, and immune response of AFX3772 in healthy infants aged 42 days and older. The trial enrolled 388 participants and was conducted in the United States and Puerto Rico.
AFX3772 is being studied as a vaccine. The Phase 2 clinical trial NCT05412030 evaluated the safety, tolerability, and immune response of AFX3772 in healthy infants. It is designed to prevent bacterial pneumonia and pneumococcal infections, not to treat existing infections.