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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01761435 | Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination | PHASE3 | COMPLETED | 499 | — | — | Oct 1, 2012 | Jan 1, 2014 | May 1, 2015 | 12 | Spain |
Difference in seroconversion rates in both treatment groups at 5, 10, 15 weeks, and 12 months after the first vaccine dose (percent of patients with 4 x increase in the pre-vaccination titers).
| Arm | Type | Description |
|---|---|---|
| Influenza vaccine, second administration after 5 weeks | EXPERIMENTAL | Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first one. |
| Influenza vaccine | ACTIVE_COMPARATOR | Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline. |
| Name | Type | Description |
|---|---|---|
| Influenza vaccine | BIOLOGICAL | Patients will be randomized at 1:1 rate and open label fashion, according to centers, and time elapsed since transplant and type of organ transplanted to one of this two interventions : A arm (usual treatment): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline. B arm (experimental branch): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first dose. The follow-up of both arms will be at 5, 10 and 15 weeks and one year after the baseline. |
Inclusion Criteria: 1. Solid organ transplant recipient. 2. 16 years or older. 3. More than 30 days after transplantation. 4. Negative pregnancy test for women of childbearing potential 5. The patient must give informed consent Exclusion Criteria: 1. No written informed consent. 2. Acute rejectio...