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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...
It is a quadrivalent recombinant influenza vaccine, also called RIV4, developed by Sanofi for the 2022-2023 season. It is designed for influenza immunization and is given to help protect against influenza. It is a vaccine modality and is identified in clinical study records as Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH.
It is used for influenza immunization. The vaccine is intended to protect against influenza, and the clinical study of this asset enrolled healthy volunteers from 9 years of age and older. Its development is focused on the infectious disease therapeutic area, specifically prevention of influenza through vaccination.
Sanofi makes it. Sanofi, which trades under the ticker SNY, is the developer of the Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH. The vaccine is part of Sanofi's influenza vaccine work and is listed under the company's development pipeline for the 2022-2023 season.
It is in Phase 3 development. The single registered trial for this vaccine, NCT05513053, is a Phase 3 study, and that trial has been completed. The vaccine is an investigational asset in clinical development rather than a newly approved product, based on the trial stage recorded for this season-specific formulation.
It has been studied in one clinical trial, NCT05513053, titled Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age. That Phase 3 trial is completed and enrolled 1,308 participants across the United States, Czechia, Poland, and Spain. It was a controlled study with healthy volunteers.
Yes. RIV4 is the alternative name for the Quadrivalent Recombinant influenza vaccine season/2022-2023/NH. The full designation used in study records is Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH, so searches for RIV4 refer to the same Sanofi quadrivalent recombinant influenza vaccine asset.