Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent Recombinant influenza vaccine season/2022-2023/NH · 1 trial · 1 indication
GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (\>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer \>= 1:10 at Day 1 and a \>= 4-fold increase in post-vaccination titer.
| Arm | Type | Description |
|---|---|---|
| Group 9 to 17 years old | EXPERIMENTAL | Participants of 9 to 17 years old who received RIV4 single intramuscular (IM) injection at D01 |
| Group 18 to 49 years old | EXPERIMENTAL | Participants of 18 to 49 years old who received RIV4 single intramuscular (IM) injection at D01 |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH | BIOLOGICAL | Pharmaceutical form: Solution for injection Route of administration: intramuscular |
Inclusion Criteria: * Aged 9 to 49 years on the day of inclusion * A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: 1) was of non-childbearing potential. To be considered of non-childbearing potential, a female sh...