Clinical Research Directory

A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers

The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.

A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in Adult Participants ≥60 Years of Age

The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years.

Phase I Clinical Trial of Lyophilized Respiratory Syncytial Virus mRNA Vaccine in Adults Aged 18 Years or Above

The primary objective of this study is to evaluate the tolerability, reactogenicity and safety of a single injection of three dose levels of ABO1105 in adults aged 18 years or above.

Phase II Clinical Trial of Lyophilized Respiratory Syncytial Virus mRNA Vaccine in Adults Aged 50 Years or Above

The primary objective of this study is to evaluate the immunogenicity and safety of a single injection of two dose levels of ABO1105 in adults aged 50 years or above.

A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea

This study is conducted as part of the local risk management plan to collect and understand the following information about the surveillance drug under the real-world clinical practice settings. To evaluate the safety of Beyfortus in Korean children who received Beyfortus under the real-world clinical practice settings per the approved indication. The investigator will decide whether to enroll participants if they determine that administering Beyfortus according to current practice can provide clinical benefits in terms of safety and efficacy Participants will be followed-up for 180 days after Beyfortus administration.

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to \<24 months.

STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON)

This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical encounters available in health records, supplemented with information from the official national immunisation registry, the Australian Immunisation Register. Additional data from accredited pathology laboratories will be included. There will be no active enrollment of study participants, no direct contact with study participants, and no collection of any primary data outside of the standard of care. This study will use a test negative design to evaluate real-world vaccine effectiveness of RSVpreF vaccination during pregnancy against RSV-associated outcomes in infants.

Impact and Effectiveness of ABRYSVO® Vaccination During Pregnancy

This study will be conducted in collaboration with a research network of independent hospital sites to evaluate the vaccine effectiveness (VE) and impact of ABRYSVO vaccination during pregnancy in a real-world population over multiple seasons, which began in 2024 across Argentina and beginning in 2025 in Uruguay. We will use three retrospective design approaches in this study: (i) a test negative design (TND) to evaluate real-world VE of maternal ABRYSVO against RSV-associated outcomes in infants; (ii) a descriptive cohort design to evaluate the clinical evolution of infants hospitalized with RSV-positive lower respiratory tract disease (LRTD); and (iii) an ecologic before-and-after design to evaluate the impact of ABRYSVO vaccination during pregnancy on infant RSV-associated and all-cause respiratory outcomes.

A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults

The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to \<60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).

Assessing Antiviral Treatments in Early Symptomatic RSV

This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated Respiratory Syncytial Virus (RSV), to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential adaptive platform trial, we will assess and compare the performance of currently licensed interventions (including repurposed drugs) with activity against RSV, and those with potential activity demonstrated in pre-clinical and early clinical studies relative to each-other, and the control (no antiviral treatment). ARSYNAL-FC study is funded by Wellcome Trust Grant ref: 226933/Z/23/Z through the COVID-19 Therapeutics Accelerator

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine

This is a randomised, double-blind, placebo-controlled Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.