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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02091908 | Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Underlying Medical Conditions | PHASE3 | COMPLETED | 540 | — | — | Apr 1, 2014 | Apr 1, 2015 | Nov 4, 2016 | 6 | Germany |
Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects who were seronegative at baseline \[day 1 HI titer \<1:10\] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline \[day 1 HI titer ≥1:10\])
In pooled age groups 18 years of age and older subjects who are healthy or with underlying medical condition who have received aTIV or aH5N1 vaccine.
| Arm | Type | Description |
|---|---|---|
| Arm 1: aH5N1 adult | EXPERIMENTAL | aH5N1 healthy and non-healthy adults |
| Arm 2: aH5N1 elderly | EXPERIMENTAL | aH5N1 healthy and non-healthy elderly |
| Arm 3: aTIV adult | ACTIVE_COMPARATOR | aTIV healthy and non-healthy adults |
| Arm 4: aTIV elderly | ACTIVE_COMPARATOR | aTIV healthy and non-healthy elderly |
| Name | Type | Description |
|---|---|---|
| Novartis Investigational H5N1 vaccine | BIOLOGICAL | 2 doses of 0.5 ml, 3 weeks apart |
| Novartis Seasonal Influenza Vaccine | BIOLOGICAL | 2 doses of 0.5 ml, 3 weeks apart |
Inclusion Criteria: * \- Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry; * Individuals who are able to compl...