SP0125 / Sanofi - LARVOL DELTA

OPAL: A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=42 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | N=947 ➔ 42

Enrollment change • Head-to-Head • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety, immunogenicity, and dose ranging of a bivalent respiratory syncytial virus and human metapneumovirus glycoprotein F-molecular clamp vaccine candidate in older adults: 1-month interim analysis of an ongoing randomised, observer-blind, placebo- and active-controlled, phase 1 trial. (PubMed, Vaccine) - "VXB-241 showed a clinically acceptable safety and reactogenicity profile and elicited strong neutralising immune responses against RSV and hMPV in older adults. Neutralising immune responses against RSV-A and RSV-B by VXB-241 were at least as good as those obtained with the licensed adjuvanted RSVPreF3 active control."

First-in-human • Journal • P1 data • Geriatric Disorders • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age (clinicaltrials.gov) - P1 | N=240 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older (clinicaltrials.gov) - P1 | N=390 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Landscape Review of the Implementation of infant RSV Prophylaxis Programs in Canada (RSVVW 2026) - "In 2024, nirsevimab and maternal RSV vaccine (RSVpreF) were introduced as prevention strategies across Canada's 13 jurisdictions, each independently managing their healthcare systems and immunization schedules. These results align with randomized clinical trial efficacy and the feasibility of rapid, large-scale immunization implementation. Canada's decentralized healthcare model created a natural experiment in program design, offering actionable insights to protect infants against severe RSV disease."

Review • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Efficacy, safety and immunogenicity of an RSV mRNA vaccine candidate in adults 60 years and older: a multicenter, randomized, placebo controlled, phase 2b study (RSVVW 2026) - "To evaluate the efficacy of messenger ribonucleic acid (mRNA) Respiratory syncytial virus (RSV) vaccine for prevention of RSV-LRTD and RSV-ARD...Funding and Conflict of Interests: Study was funded by Sanofi. All authors are Sanofi employees and may hold company shares and/stock options."

Clinical • P2b data • Respiratory Diseases • Respiratory Syncytial Virus Infections

GLORY - GLObal RespiratorY viruses study - Assessing global epidemiology of a broad panel of respiratory viruses through case-based data (RSVVW 2026) - "The recent expansion of multiplex testing and the development of new preventive tools (such as RSV vaccines and monoclonal antibodies, and emerging candidates for other viruses) have renewed the need for high-quality comparative data...Information from the questionnaires will support the interpretation of these findings in relation to differences in surveillance systems, case definitions and testing strategies, and will help inform the timing and geographical tailoring of future prevention strategies.The GLORY project is sponsored by the University of Florence and is co-funded by Sanofi. OM is an employee of and may own shares/stock options in Sanofi."

Clinical • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

GLORY - GLObal RespiratorY viruses study - Assessing global epidemiology of a broad panel of respiratory viruses through case-based data. (RSVVW 2026) - "The recent expansion of multiplex testing and the development of new preventive tools (such as RSV vaccines and monoclonal antibodies, and emerging candidates for other viruses) have renewed the need for high-quality comparative data...The GLORY project is sponsored by the University of Florence and is co-funded by Sanofi. OM is an employee of and may own shares/stock options in Sanofi."

Clinical • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Beyond Titres: Defining RSV Vaccination Window and Functional Antibody Responses in Kenyan Children (RSVVW 2026) - "To ensure optimal effectiveness of this vaccine and future RSV vaccines, especially after the COVID-19 pandemic, a suitable vaccination window needs to be determined...The neutralization assay is ongoing, and results will be shared once the data is analysed. This study informs evidence-based vaccine timing and challenges reliance on antibody titres alone to conclude immune protective capacity of RSV antibodies."

Clinical • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

OPAL: A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=947 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Apr 2026 ➔ Jun 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2026 ➔ Jun 2025; Sponsor decision

Head-to-Head • Trial completion date • Trial primary completion date • Trial termination • Respiratory Diseases • Respiratory Syncytial Virus Infections

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Terminated; Sponsor decision

Trial termination • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

PEARL: Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=6300 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Dec 2027 ➔ Dec 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: May 2026 ➔ Dec 2025; Sponsor decision

Trial completion date • Trial primary completion date • Trial termination • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older (clinicaltrials.gov) - P1/2 | N=1530 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Sep 2027 ➔ Jan 2027 | Trial primary completion date: Jul 2027 ➔ Jan 2027

Trial completion date • Trial primary completion date • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years (clinicaltrials.gov) - P1 | N=385 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age (clinicaltrials.gov) - P1 | N=240 | Active, not recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections

Live-Attenuated Intranasal RSV Vaccine in Infants and Toddlers. (PubMed, NEJM Evid) - P1/2 | "The RSVt vaccine demonstrated promising immunogenicity profiles at both LD and HD strengths among infants and toddlers, without identified safety concerns. (Funded by Sanofi; ClinicalTrials.gov number, NCT04491877)."

Clinical • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age (clinicaltrials.gov) - P1 | N=240 | Not yet recruiting | Sponsor: Sanofi

New P1 trial • Respiratory Diseases • Respiratory Syncytial Virus Infections

Hospitalisation trends of respiratory syncytial virus (RSV) infection in adults, six European countries, before and during COVID-19, 2016 to 2023. (PubMed, Euro Surveill) - "The differences between the numbers of RSV-coded and laboratory-confirmed cases highlight the critical need for improved surveillance, diagnostic practices and coding guidelines to better assess the incidence. Our findings could be vital for guiding public health strategies, particularly with the introduction of RSV vaccines for older adults."

Journal • Retrospective data • Critical care • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older (clinicaltrials.gov) - P1/2 | N=1530 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older (clinicaltrials.gov) - P1/2 | N=865 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years (clinicaltrials.gov) - P1 | N=385 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older (clinicaltrials.gov) - P2 | N=4541 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older (clinicaltrials.gov) - P1 | N=390 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV Prevention Strategies in Korean Children: A Review of Current Approaches and Emerging Options. (PubMed, Infect Chemother) - "Current preventive measures, such as palivizumab, have limitations, necessitating the exploration of new strategies...While several RSV vaccines are under development, none are currently available in Korea...This review highlights the evolving landscape of RSV prevention, with a shift towards nirsevimab and future vaccines. Further research is crucial to understand the long-term consequences of RSV infection and develop comprehensive prevention strategies tailored to the Korean population."

Journal • Review • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA) (clinicaltrials.gov) - P1/2 | N=80 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed | Trial completion date: May 2025 ➔ Dec 2024 | Trial primary completion date: May 2025 ➔ Dec 2024

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections