Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05412030 | A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants | PHASE2 | COMPLETED | 388 | — | — | Jun 16, 2022 | Sep 18, 2025 | Oct 21, 2025 | 46 | United States, Puerto Rico |
The assessed solicited injection site events are tenderness, redness/erythema and swelling.
The assessed solicited systemic events are irritability, fever, decrease of appetite, increased sleep, and decrease in sleep.
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.
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 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). |
| 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. |
| 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. |
| Part 1 Group 4 | ACTIVE_COMPARATOR | PCV13 administered intramuscularly within 12 months. |
| 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. |
| 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. |
| Part 2 Group 7 | ACTIVE_COMPARATOR | PCV20 administered intramuscularly within 12 months. |
| Name | Type | Description |
|---|---|---|
| AFX3772 | BIOLOGICAL | AFX3772 administered intramuscularly. |
| Prevnar 13 | BIOLOGICAL | PCV13 administered intramuscularly. |
| Prevnar 20 | BIOLOGICAL | PCV 20 administered intramuscularly. |
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 formulatio...