Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
One dose of investigational vaccine · 1 trial · 1 indication
Safety index-After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 were reported. The solicited local symptoms include pain, induration, redness, swelling, rash, and pruritus. The solicited general adverse symptoms include allergy, fatigue, irritability, inappetence, vomiting, diarrhea, and fever. Unsolicited adverse events on day 0-30 were also reported, which include the unsolicited symptoms happened within 0-7 days, and any symptoms happened within the 8-28 days. Each AE case will be reviewed by the investigator to determine whether it was an adverse reaction (The vaccination-related AE). The incidence of adverse reactions=Number of subjects who have adverse reactions of any symptoms/number of all the subjects whose safety information are collected.
| Arm | Type | Description |
|---|---|---|
| Adults-Experimental group | EXPERIMENTAL | One dose of investigational vaccine |
| Children-Experimental group | EXPERIMENTAL | One dose of investigational vaccine |
| Children-Control group | ACTIVE_COMPARATOR | One dose of control vaccine |
| Neonates-Experimenatal group | EXPERIMENTAL | Three doses of investigational vaccine |
| Neonates-Control group | ACTIVE_COMPARATOR | Three doses of control vaccine |
| Name | Type | Description |
|---|---|---|
| One dose of investigational vaccine | BIOLOGICAL | One dose of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research \& Development Co., Ltd. |
| One dose of control vaccine | BIOLOGICAL | One dose of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc. |
| Three doses of investigational vaccine | BIOLOGICAL | Three doses of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research \& Development Co., Ltd. on the schedule of month 0,1,2 |
| Three doses of control vaccine | BIOLOGICAL | Three doses of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc. |
Inclusion Criteria: * Adults aged 18\~49 years, or children aged 1\~15 years, or neonates within 24 hours of birth; * Proven legal identity; * Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollmen...
One dose of investigational vaccine is being studied for the prevention of Hepatitis B, an infectious disease. It is currently in Phase 1 clinical development and is being evaluated in a clinical trial in China. The vaccine is intended for healthy volunteers, as indicated by the trial design.
One dose of investigational vaccine is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company. The company is conducting a Phase 1 clinical trial for this vaccine candidate, which is designed to target Hepatitis B. Sinovac Biotech is listed on the stock exchange under the ticker SVA.
One dose of investigational vaccine is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not yet been approved for use. The Phase 1 trial has been completed, and the vaccine is being studied for its safety and immunogenicity in healthy volunteers for Hepatitis B.
One dose of investigational vaccine has been studied in a single clinical trial with the identifier NCT04075201. This trial, titled 'Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg)', was a Phase 1 study that has been completed. The trial enrolled 144 participants in China and was randomized, double-blind, and active-controlled.
One dose of investigational vaccine is being evaluated in a clinical trial for a recombinant Hepatitis B vaccine. The trial NCT04075201 tests a recombinant Hepatitis B vaccine produced in Hansenula polymorpha, with a 10μg dose. This vaccine candidate is being developed by Sinovac Biotech for the prevention of Hepatitis B.