Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains · 1 trial · 2 indications
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28.
| Arm | Type | Description |
|---|---|---|
| Group 1: QIV-HD | EXPERIMENTAL | Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. |
| Group 2: QIV-SD | ACTIVE_COMPARATOR | Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0. |
| Name | Type | Description |
|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD) | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM |
| Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD) | BIOLOGICAL | Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: SC |
Inclusion criteria : * Aged greater than or equal to (\>=) 60 years on the day of inclusion. * Able to attend all scheduled visits and complied with all study procedures. Exclusion criteria: * Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or pla...