Recent Updates
Recently added Catalysts

Quadrivalent Recombinant Influenza Vaccine

Phase 3

Influenza (Healthy Volunteers) | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 11, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment301
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05144945Study Describing the Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Licensed Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix® Quadrivalent) in Participants 18 Years of Age and Older in South KoreaPHASE3 COMPLETED 301Dec 7, 2021Sep 1, 2022Sep 11, 20253 South Korea
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)
Day 1 (pre-vaccination)

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.

Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)
Day 1 (pre-vaccination)

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.

Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPAS
Day 29 (post-vaccination)

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.

Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FAS
Day 29 (post-vaccination)

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.

Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPAS
Day 1 (pre-vaccination) and Day 29 (post-vaccination)

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).

Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FAS
Day 1 (pre-vaccination) and Day 29 (post-vaccination)

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).

Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPAS
Day 29 (post-vaccination)

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.

Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FAS
Day 29 (post-vaccination)

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.

Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS
Day 1 (pre-vaccination) and Day 29 (post-vaccination)

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.

Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS
Day 1 (pre-vaccination) and Day 29 (post-vaccination)

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.

Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS
Day 1 (pre-vaccination) and Day 29 (post-vaccination)

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.

Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS
Day 1 (pre-vaccination) and Day 29 (post-vaccination)

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.

Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
Within 30 minutes post-vaccination

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.

Number of Participants Reporting Solicited Systemic Reactions
Within 7 days post-vaccination

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.

Number of Participants Reporting Solicited Injection Site Reactions
Within 7 days post-vaccination

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.

Number of Participants Reporting Unsolicited Adverse Events (AEs)
From Day 1 up to 28 days post-vaccination (i.e., up to Day 29)

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.

Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
From Day 1 up to 6 months post-vaccination (i.e., up to Day 181)

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.

Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)EXPERIMENTALParticipants received a single intramuscular (IM) injection of 0.5 milliliters (mL) RIV4 on Day 1.
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)ACTIVE_COMPARATORParticipants received a single IM injection of 0.5 mL IIV4 on Day 1.
Interventions
NameTypeDescription
Quadrivalent Recombinant Influenza Vaccine (RIV4)BIOLOGICALSolution for intramuscular injection
Quadrivalent inactivated influenza vaccine (IIV4)BIOLOGICALSuspension for intramuscular injection
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites3

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...

Countries:South Korea
Unlock Eligibility Criteria