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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00835380 | A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069) | PHASE3 | COMPLETED | 80 | — | — | Mar 1, 2008 | Oct 1, 2008 | Apr 13, 2017 | - | — |
Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines. HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer \< 50 mIU/mL.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | VAQTA™ |
| Name | Type | Description |
|---|---|---|
| Hepatitis A Vaccine, Purified Inactivated (VAQTA™) | BIOLOGICAL | Subjects will be given a 25-U/0.5 mL intramuscular injections of VAQTA™ at Day 1 and Month 6. |
Inclusion Criteria: * Healthy Chinese children 12 to 17 months old at receipt of the first study vaccination Exclusion Criteria: * Subject is Hepatitis A virus antibody positive at screening or has a history of Hepatitis A infection * Subject has a fever 72 hours prior to first injection * Subjec...