Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
1.0 cc HBVAXPRO 10mcgr/ml · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Intramuscular group | ACTIVE_COMPARATOR | These subjects will receive one intramuscular injection of 1.0cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur-MSD) with syringe and needle in the deltoid region. |
| Intradermal group (Mantoux) | EXPERIMENTAL | These subjects will receive one intradermal injection with mantoux technique in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur-MSD) will be injected. |
| Intradermal group (VAX-ID) A | EXPERIMENTAL | These subjects will receive one intradermal injection with the newly developed intradermal injection device VAX-ID in the forearm. 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected. |
| Intradermal group (VAX-ID) B | EXPERIMENTAL | These subjects will receive two intradermal injections with two newly developed intradermal injection devices VAX-ID in both forearms each 0.1cc of HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) will be injected. |
| Name | Type | Description |
|---|---|---|
| VAX-ID | DEVICE | 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection |
| 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) | DRUG | 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD) |
| 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) | DRUG | 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection |
Inclusion Criteria: * healthy adults, checked anamnestically (based on medical history) at entry of the study * 18-35 years * vaccination status: fully vaccinated against hepatitis B at least 5 years ago, with proof of vaccine response (to avoid non-response among the subjects). Subjects has to ask...
HBVAXPRO 10mcgr/ml is a vaccine used for Hepatitis B. It is an investigational product being studied for the prevention of Hepatitis B infection. The vaccine is currently in Phase 1 clinical development.
HBVAXPRO 10mcgr/ml is being developed by OraSure Technologies, Inc. (NASDAQ: OSUR). The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity for Hepatitis B.
HBVAXPRO 10mcgr/ml is in Phase 1 clinical development. It is an investigational vaccine for Hepatitis B and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
HBVAXPRO 10mcgr/ml has one completed clinical trial, NCT02186977, titled "Proof Of Concept: Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID." This Phase 1 study enrolled 48 participants in Belgium and evaluated the vaccine in healthy volunteers.
HBVAXPRO 10mcgr/ml is a Hepatitis B vaccine. In the clinical trial NCT02186977, it is referred to as "hepB Injection." The study evaluates the immunogenicity and safety of this Hepatitis B vaccine when administered into the dermis.