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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01014845 | Clinical Trial of Recombinant Hepatitis E Vaccine | PHASE3 | COMPLETED | 112,604 | — | — | Aug 1, 2007 | Oct 1, 2017 | Jul 13, 2020 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| Hepatitis E vaccine | EXPERIMENTAL | Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. |
| HBV vaccine | PLACEBO_COMPARATOR | Hepatitis B vaccine, containing 5mcg of HBsAg recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. |
| Name | Type | Description |
|---|---|---|
| hepatitis E vaccine | BIOLOGICAL | Intramuscularly given at 0, 1, 6m for three doses. |
| Hepatitis B vaccine | BIOLOGICAL | Intramuscularly given at 0, 1, 6m for three doses. |
Inclusion Criteria: * Healthy people aged from 16 years to 65 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form. * Subjects will reside in the study region in the next 19 months. * Free of history of hepatitis B or hepatitis E. * Can com...