Flublok Quadrivalent (influenza vaccine) / Sanofi - LARVOL DELTA

A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age. (clinicaltrials.gov) - P1 | N=270 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age. (clinicaltrials.gov) - P1 | N=270 | Not yet recruiting | Sponsor: Sanofi

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Immunogenicity Trial of 3 Influenza Vaccines (clinicaltrials.gov) - P3 | N=366 | Completed | Sponsor: Tan Tock Seng Hospital | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Alternative approach to Enhanced Passive Safety Surveillance study for post-marketing monitoring of a flu vaccine in Great Britain: The Supemtek® case (ISIRV-OPTIONS XII 2024) - No abstract available

Clinical • P4 data

A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above (clinicaltrials.gov) - P1/2 | N=1002 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Comparison of Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years (clinicaltrials.gov) - P4 | N=3988 | Terminated | Sponsor: Fatimah Dawood | Active, not recruiting ➔ Terminated; Insufficient funding.

IO biomarker • Trial termination • Infectious Disease • Influenza • Respiratory Diseases • CD4 • CD40LG • CD8 • GZMB • IFNG • IL17A • IL2 • IL2RA • IL4 • LAMP1 • TNFA

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=682 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above (clinicaltrials.gov) - P1 | N=159 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=682 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above (clinicaltrials.gov) - P1/2 | N=1002 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P1/2 trial • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=560 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Flublok Quadrivalent Vaccine Adjuvanted with R-DOTAP Elicits a Robust and Multifunctional CD4 T Cell Response That Is of Greater Magnitude and Functional Diversity Than Conventional Adjuvant Systems. (PubMed, Vaccines (Basel)) - "The elicited CD4+ T cells specific for HA-derived epitopes produce IL-2, IFN-γ, IL-4/5, and granzyme B and have multifunctional potential. Hence, R-DOTAP, which has been verified safe by human studies, can offer exciting opportunities as an immune stimulant for next-generation prophylactic recombinant protein-based vaccines."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CD4 • GZMB • IFNG • IL2 • IL4

FLUO: Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients (clinicaltrials.gov) - P3 | N=206 | Completed | Sponsor: Assistance Publique - Hôpitaux de Paris | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Infectious Disease • Influenza • Obesity • Respiratory Diseases

Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age. (clinicaltrials.gov) - P3 | N=1323 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years (clinicaltrials.gov) - P3 | N=366 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | N=1412 ➔ 366 | Recruiting ➔ Terminated; Sponsor decision to prematurely stop the study. This decision was made without any safety concerns.

Enrollment change • Trial termination • Infectious Disease • Influenza • Respiratory Diseases

Recombinant or Standard-Dose Influenza Vaccine in Adults under 65 Years of Age. (PubMed, N Engl J Med) - P=N/A | "The high-dose recombinant vaccine conferred more protection against PCR-confirmed influenza than an egg-based standard-dose vaccine among adults between the ages of 50 and 64 years. (Funded by Sanofi; ClinicalTrials.gov number, NCT03694392.)."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above (clinicaltrials.gov) - P1 | N=159 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older (clinicaltrials.gov) - P1 | N=388 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases

FLUO: Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients (clinicaltrials.gov) - P3 | N=206 | Active, not recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Trial primary completion date: Oct 2023 ➔ Apr 2023

Trial primary completion date • Genetic Disorders • Infectious Disease • Influenza • Obesity • Respiratory Diseases

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=684 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older (clinicaltrials.gov) - P1/2 | N=560 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Comparison of Recombinant Influenza Vaccine Versus Standard Egg-Based Inactivated Influenza Vaccine in Adults 18-64 Years (clinicaltrials.gov) - P4 | N=3988 | Active, not recruiting | Sponsor: Fatimah Dawood | Recruiting ➔ Active, not recruiting | N=16247 ➔ 3988 | Trial completion date: Sep 2024 ➔ Dec 2023 | Trial primary completion date: Jun 2024 ➔ Dec 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age. (clinicaltrials.gov) - P3 | N=1323 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above. (clinicaltrials.gov) - P1 | N=225 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases

RIVER: Randomized Influenza Vaccine Evaluation of Immune Response (clinicaltrials.gov) - P4 | N=366 | Active, not recruiting | Sponsor: Marshfield Clinic Research Foundation | Trial completion date: Sep 2022 ➔ Dec 2023

Trial completion date • Infectious Disease • Influenza • Respiratory Diseases