Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
High-Dose trivalent influenza vaccine · 1 trial · 1 indication
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage.
Anti-influenza antibodies will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Seroconversion status 28 days after vaccination (ie, preinjection Ab titer \< 10 \[1/dil\] at Day 1 and post-injection Ab titer≥ 40 \[1/dil\] at Day 29 or preinjection Ab titer ≥ 10 \[1/dil\] at Day 1 and a ≥ 4-fold increase in titer \[1/dil\] at Day 29).
| Arm | Type | Description |
|---|---|---|
| IIV-HD | EXPERIMENTAL | Participants will receive a single intramuscular (IM) injection of IIV-HD at Day 1 |
| IIV-SD | ACTIVE_COMPARATOR | Participants will receive a single intramuscular (IM) injection of IIV-SD at Day 1 |
| Name | Type | Description |
|---|---|---|
| High-Dose trivalent influenza vaccine (Split virion, Inactivated) | BIOLOGICAL | Liquid suspension for intramuscular injection |
| Standard-dose trivalent influenza vaccine (Split virion, Inactivated) | BIOLOGICAL | Liquid suspension for intramuscular injection |
Inclusion Criteria: * Aged 50 to 64 years on the day of inclusion. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female m...