Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent Recombinant Influenza Vaccine · 1 trial · 1 indication
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1).
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1).
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) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 29.
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) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 29.
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the study intervention administered. Solicited systemic reactions included fever, headache, malaise, myalgia, shivering, fatigue, nausea, and arthralgia.
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the study intervention administered. Solicited injection site reactions included pain, erythema, swelling, induration, bruising and tenderness.
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination.
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. An AESIs were defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
| Arm | Type | Description |
|---|---|---|
| Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4) | EXPERIMENTAL | Participants received a single intramuscular (IM) injection of 0.5 milliliters (mL) RIV4 on Day 1. |
| Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4) | ACTIVE_COMPARATOR | Participants received a single IM injection of 0.5 mL IIV4 on Day 1. |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Recombinant Influenza Vaccine (RIV4) | BIOLOGICAL | Solution for intramuscular injection |
| Quadrivalent inactivated influenza vaccine (IIV4) | BIOLOGICAL | Suspension for intramuscular injection |
Inclusion Criteria: * Aged \>=18 years on the day of inclusion. * Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination. * Able to attend all scheduled visits and complied with all study procedures. * Informed consent form was sign...
Quadrivalent Recombinant Influenza Vaccine is an investigational vaccine being studied for the prevention of influenza in healthy volunteers aged 18 years and older. It is designed to provide protection against four influenza virus strains. The vaccine is currently in Phase 3 clinical development.
Quadrivalent Recombinant Influenza Vaccine is being developed by Sanofi, a global biopharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY. The vaccine is currently in Phase 3 clinical development for the prevention of influenza.
Quadrivalent Recombinant Influenza Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The vaccine is being studied for the prevention of influenza in healthy adults aged 18 years and older.
Quadrivalent Recombinant Influenza Vaccine has one completed Phase 3 clinical trial, identified as NCT05144945. This trial was a randomized, double-blind, active-controlled study conducted in South Korea, comparing the vaccine to a licensed quadrivalent inactivated influenza vaccine in 301 participants aged 18 years and older.
No, Quadrivalent Recombinant Influenza Vaccine is not the same as Fluarix Quadrivalent. In clinical trial NCT05144945, Fluarix Quadrivalent was used as the active comparator, meaning it was the licensed vaccine against which the investigational vaccine was compared. The two vaccines are different products.