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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00792623 | Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM). | PHASE2 | COMPLETED | 45 | — | — | Sep 8, 2003 | Sep 10, 2007 | Nov 8, 2018 | 3 | Australia |
Vaccine response was defined as: for initially seropositive subjects, an antibody titer at Month 8 post-transplantation above or equal to (≥) 4 fold the pre-vaccination antibody titer.
Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
| Arm | Type | Description |
|---|---|---|
| Varilrix Group | EXPERIMENTAL | Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation. |
| Name | Type | Description |
|---|---|---|
| VarilrixTM | BIOLOGICAL | Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm. |
Inclusion Criteria: Screening phase: * A male or female ≥ 18 years of age at the time of study entry. * Written informed consent obtained from the subject prior to study entry. * Patients who are planned to undergo autologous peripheral stem cell/ bone marrow transplantation. * Subjects who the in...