Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SA3Ag vaccine · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | SA3Ag in both stage 1 and stage 2 |
| 2 | EXPERIMENTAL | SA3Ag in stage 1 followed by placebo in stage 2. |
| 3 | PLACEBO_COMPARATOR | Placebo in both stage 1 and stage 2 |
| 4 | EXPERIMENTAL | SA3Ag in stage 1 and no vaccine in stage 2. |
| 5 | PLACEBO_COMPARATOR | Placebo in stage 1 and no vaccine in stage 2. |
| Name | Type | Description |
|---|---|---|
| SA3Ag vaccine | BIOLOGICAL | In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses: Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm In stage 2 the subject will receive 0.5 mL IM of the same dose level he/she received in stage 1. |
| Blood draw | PROCEDURE | Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1. |
| Colonization swab samples | PROCEDURE | Colonization swabs will be taken at timepoints throughout stage 1 and stage 2. |
| SA3Ag followed by Placebo | BIOLOGICAL | In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses: Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm In stage 2 the subject will receive one injection of 0.5 mL IM of the placebo. |
| Placebo | BIOLOGICAL | In both stage 1 and stage 2, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl for a total of 2 injections throughout the study. |
| SA3Ag with no booster in stage 2 | BIOLOGICAL | In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses: Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm In stage 2 the subject will receive no vaccine. |
| Placebo with no booster in stage 2 | PROCEDURE | In stage 1, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl. In stage 2 the subject will receive no vaccine. |
Inclusion Criteria: * Healthy adults aged 18 to 24 years or 50 to 85 years who are available for the entire duration of the study, able to be contacted by phone, and able to complete all study procedures, including completion of an electronic diary (e-diary). * Men and women who are able to have ch...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
The SA3Ag vaccine is an investigational 3-antigen Staphylococcus aureus vaccine developed by Pfizer, Inc. It is designed to prevent bacterial infections caused by Staphylococcus aureus, including staphylococcal skin infections. It is a vaccine modality and has been studied in healthy adult volunteers.
The SA3Ag vaccine is being developed for the prevention of bacterial infections, specifically Staphylococcal infections and Staphylococcal skin infections. It is intended for use in healthy adults. It remains investigational and is not an approved product.
The SA3Ag vaccine is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical evaluation of the vaccine in healthy adults.
The SA3Ag vaccine is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 trial evaluating the vaccine has been completed.
The SA3Ag vaccine has been studied in one completed Phase 1 trial, NCT01018641, titled An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults. The trial enrolled 449 healthy adult participants in Australia and was randomized, double-blind, and placebo-controlled.