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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00464672 | Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old | PHASE3 | COMPLETED | 1,893 | — | — | Apr 1, 2007 | Dec 1, 2007 | Oct 1, 2015 | 2 | Argentina |
To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.
| Arm | Type | Description |
|---|---|---|
| Influenza virus vaccine | EXPERIMENTAL | - |
| Comparator influenza vaccine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Influenza virus vaccine | BIOLOGICAL | Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age. |
| Comparator influenza vaccine | BIOLOGICAL | Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age. |
Inclusion Criteria: * Healthy subjects 3 to 64 years of age Exclusion Criteria: * Receipt of other investigational products within 3 months or other vacine within 1 month; * Allergy to eggs, egg products, or any other vaccine component; * Laboratory confirmed influenza disease within 6 months; * ...