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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03282240 | Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US | PHASE3 | COMPLETED | 2,670 | — | — | Sep 8, 2017 | Apr 19, 2018 | Apr 7, 2022 | 36 | United States |
GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (\<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (\>=) 40 (1/dilution) at Day 28, or HAI titer \>=10 (1/dilution) at Day 0 and a \>=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
| Arm | Type | Description |
|---|---|---|
| QIV-HD | EXPERIMENTAL | Participants randomized to receive a single injection of 0.7 mL QIV-HD by intramuscular (IM) route at Day 0. |
| TIV-HD1 (Licensed TIV-HD1) | ACTIVE_COMPARATOR | Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0. |
| TIV-HD2 (Investigational TIV-HD2) | ACTIVE_COMPARATOR | Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. |
| Name | Type | Description |
|---|---|---|
| QIV-HD | BIOLOGICAL | 0.7 mL-dose was administered intramuscularly (IM) into the upper arm area. |
| Licensed TIV-HD1 | BIOLOGICAL | 0.5 mL-dose was administered IM into the upper arm area. |
| Investigational TIV-HD2 | BIOLOGICAL | 0.5 mL-dose was administered IM into the upper arm area. |
Inclusion Criteria: * Aged \>= 65 years on the day of inclusion. * Informed consent form had been signed and dated. * Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: * Participation at the time of trial enrollment (or in the 4 weeks preceding the t...