SP0125 / Sanofi - LARVOL DELTA

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

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age (clinicaltrials.gov) - P1 | N=81 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Apr 2024

Trial completion • Trial completion date • Infectious Disease • 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 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • 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 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • 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 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Pediatrics • 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 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • 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 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

Head-to-Head • New P3 trial • 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 | 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 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=1470 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Lipid Nanoparticle • 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=1470 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P1/2 trial • 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=390 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • 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 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • 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 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Mar 2026 ➔ Sep 2025

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