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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04075201 | Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg) | PHASE1 | COMPLETED | 144 | — | — | Jul 7, 2019 | Jul 25, 2021 | Jul 29, 2021 | 1 | China |
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...