Clinical Research Directory

A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older

This is a randomized, observer-blinded, placebo-controlled Phase III clinical trial to evaluate efficacy, immunogenicity and safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in participants aged 60 years and older.

Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients

The purpose of this study is to compare the immunogenicity and safety of respiratory syncytial virus (RSV) vaccination between lung transplant recipients and immunocompetent adults and to provide evidence to guide RSV vaccination in lung transplant recipients.

A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Older Adults

This study is testing the safety and tolerability of a second dose of Respiratory Syncytial Virus Vaccine (RSVpreF) given approximately 5 years after the initial dose.

A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Immunocompromised Adults

The purpose of this phase 3 study is to learn the safety, tolerability and immunogenicity of revaccination with RSVpreF at approximately 1-, 2-, and 3-year intervals to inform the revaccination interval in immunocompromised adults. This study is seeking participants who are 18 years of age and older and will be grouped based on prior RSV vaccination history. Participants are required to be immunocompromised per study protocol. All participants in this study will receive 1 shot to their arm of a RSVPreF vaccine. Participants will take part in this study for about 12 months and will need to visit the clinical study site at least 4 times.

THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness

RSV is a leading cause of severe respiratory illness and hospitalisation for young children, with particularly high rates of RSV respiratory infection observed amongst Aboriginal and Torres Strait Islander children living in Australia's Northern Territory. The goal of this clinical trial is to evaluate whether routinely administering a single dose of respiratory syncytial virus (RSV)-specific monoclonal antibody, nirsevimab, from 6 months old, provides protection against RSV infections for Aboriginal and Torres Strait Islander children throughout in the first and second year of life. In this study, participants will be randomly assigned to receive either a single dose of intra-muscular RSV-specific monoclonal antibody, nirsevimab, or standard care (no RSV-specific monoclonal antibody). The primary objective is to determine whether administration ofRSV-specific monoclonal antibody, nirsevimab reduces the occurrence of RSV infection over the subsequent 12 months. Secondary objectives include assessing whether nirsevimab reduces RSV-related hospital attendances, as well as respiratory and all-cause hospitalisations, over the following 6 and 12 months. An assessment of cost-effectiveness will also be undertaken. Participants will receive the study intervention at 6 months of age (+90 days). Follow-up will be conducted through passive surveillance using electronic medical records and public health notification systems to capture relevant health outcomes.

A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF

The purpose of this phase 3 multicenter, double-blinded, placebo-controlled study in India is to learn about the safety and immunogenicity of RSVpreF in adults.

A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.

The purpose of the study is to learn about the immune response after a RSVpreF vaccination. This study is being conducted in Japan. RSV is a common virus that can cause infections of the lungs and airways. The study is seeking participants who are: * 18 to 59 years of age * adults with health condition(s) that can put them at an increased risk of severe RSV disease It will also learn about the safety of RSVpreF vaccination. The study lasts about 2 months. Adults need to visit the research site at least 2 times. The participant will receive a phone call 2 months after vaccination for health checks.

Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease

The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of RSVpreF in children 5 to \<18 years of age at high risk for RSV disease, including those who are immunocompromised.

ELderly REspiratory VIral Cohort

In addition to SarsCov2, the main viral respiratory risks are associated with influenza viruses, respiratory syncytial virus (RSV), human metapneumovirus (hMPV) parainfluenza virus (PIV), adenovirus, rhinovirus, coronavirus and others. HMPV is a respiratory virus discovered in 2001. Like RSV, it appears to be a threat in terms of morbidity and mortality in susceptible populations. Overall, viral infections can cause significant functional decline in older patients, with 67% and 25% reported to be at least temporarily housebound or bedridden, respectively. Respiratory viral infections prevent older patients from functioning and performing their daily tasks. They therefore have a significant impact on the older patients and their families. In addition, respiratory viruses are key factors in the exacerbation of chronic diseases. The aims of this study are to provide a better understanding of the role of hMPV compared to common respiratory viruses on morbimortality, risk of dependency, quality of life alteration in older inpatients.

A Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of YKYY025 Injection

A Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of YKYY025 Injection

Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease

This is a Phase IV, prospective, open-label, multicentre study to evaluate the safety of palivizumab IM injection for the prevention of severe LRTD in Indian infants and children who are at high-risk of RSV disease. All enrolled participants will receive palivizumab 15 mg/kg IM injection once a month for up to 5 injections during the study. Children who undergo cardiac surgery with cardiopulmonary bypass during the study should receive an additional dose of study intervention immediately after surgery, when medically stable for IM injection as determined by the physician. Prior to each study intervention administration, all participants will undergo safety assessments. A follow-up visit will be performed telephonically with the parent(s) or legal guardian(s) of all participants 30 days after their last injection of palivizumab.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of YKYY018 for Inhalation Solution

A phase II clinical study to evaluate the efficacy and safety of YKYY018 for inhalation solution in adult participants with respiratory syncytial virus infection

Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine （CHO Cell） in Adults Aged 18 Years and Older

This phase 1 study in China will evaluate the Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged 18 Years and Older

Real-World Effectiveness of RSV Vaccines Among Adults Using Target Trial Emulation in Epic Cosmos

Among non-pregnant adults observed in Epic Cosmos since August 2023 who are eligible for RSV vaccination, what is the effectiveness of ABRYSVO® (RSVpreF), compared with unvaccinated individuals, in preventing RSV-related and all-cause acute respiratory illness (ARI), lower respiratory tract disease (LRTD), and other outcomes of interest, within a target trial emulation (TTE) framework

A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults

The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups

Systems Biological Analysis of Immune Responses to RSV Vaccine

The purpose of this study is to characterize the immune response to the FDA-approved mRNA-based RSV vaccine in adults ≥60 years of age, using a systems biology approach. The study aims to generate high-resolution immunologic and systems biology data following vaccination to identify early biomarkers of response and gain mechanistic insight into host immunity.

A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus

Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and non-hospitalized children aged ≥28 days to ≤36 months who present with symptomatic RSV infection.

Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants

To generate critical evidence to support vaccine policy and implementation, Pfizer will collaborate with Kaiser Permanente Northern California (KPNC) to study the vaccine effectiveness (VE) of ABRYSVO vaccination during pregnancy in a real-world population. The overall research question of this study is: what is the effectiveness and impact of ABRYSVO vaccination during pregnancy against medically-attended (MA) respiratory syncytial virus (RSV)-associated and all-cause infant outcomes in a large, diverse, real-world population? This study will use a retrospective cohort design and will be conducted within an integrated delivery health care organization using electronic medical record (EMR) data collected during routine standard of care clinical encounters. Study outcomes among infants born to ABRYSVO-vaccinated mothers (exposed group) will be compared with those among infants born to ABRYSVO-unvaccinated mothers (comparison group) initially from birth to ≤180 days of age, with later assessments from birth to ≤360 days of age and to ≤720 days of age as the infants reach these age thresholds and their data become available. There are two categories of outcomes of interest in this study: RSV-specific infant outcomes and non-specific all-cause infant outcomes, assessed within several follow-up windows (birth to ≤180 days of age, birth to ≤360 days of age, and/or birth to ≤720 days of age, depending on the outcome). Identification of RSV-specific outcomes will be based on the first positive laboratory-confirmed PCR test from a respiratory specimen during a healthcare encounter in a KPNC healthcare setting, occurring during the relevant follow-up window. RSV-positive test results will be combined with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic codes to define the RSV-specific outcomes. RSV-specific outcomes will include: PCR-confirmed RSV, PCR-confirmed RSV hospitalization, PCR-confirmed RSV LRTD, and PCR-confirmed RSV LRTD hospitalization. Non-specific all-cause infant outcomes will include: all-cause LRTD, all-cause LRTD hospitalization, acute otitis media, and first antibiotic prescription (for any diagnosis). Identification of these outcomes will be based on ICD-10-CM diagnostic codes documented in infant EMRs during a healthcare encounter in a KPNC healthcare setting, occurring during the relevant follow-up window.

A Study to Evaluate the Immune Response Features Following Vaccination With a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)

The purpose of this study is to elucidate the molecular mechanism by which novel adjuvants enhance the immunogenicity of Respiratory Syncytial Virus (RSV) vaccines by regulating antigen-specific B cell affinity maturation and T cell memory formation.

Transplacental Transmission of RSV (TTRSV)

Aim 1: To study transplacental transmission of Respiratory Syncytial Virus (RSV) and how this is moderated by other maternal infections during pregnancy Aim 2: To test maternal blood for presence of RSV-specific immunoglobulins and how this is moderated by other maternal infections during pregnancy Aim 3: To test cord blood (fetal blood) for presence of RSV-specific immunoglobulins and other common viral pathogens Aim 4: To perform further tests (Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), Droplet Digital Polymerase Chain Reaction (ddPCR) and immunoprobing) to confirm the presence of RSV and other common viral pathogens Aim 5: To follow these newborn infants up to 4 years of age to look for redisposition to respiratory diseases and growth parameters

Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of vaccines encoding the RSV monovalent antigen or the Flu hemagglutinin subtype 5 (H5) antigen in healthy participants aged 18 to 49 years. The total duration of study participation for each participant varies by stage and treatment arm. Stage 1: * For Arm 1, Arm 2, and Arm 3 the duration of study participation will be approximately 7 months for each participant. * For Arm 4, Arm 5, and Arm 6 the duration of study participation will be approximately 6 months for each participant. Stage 2: For all arms, the duration of study participation will be approximately 7 months for each participant.

A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV

The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, the prevention of Respiratory Syncytial Virus (RSV) infection and diseases. Participants will be randomized to receive either JCXH-108 or placebo.

Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women

A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age

TARSILA Real-World Evidence Study

The overall objective of Tarsila Study is to estimate the real-world vaccine effectiveness of maternal RSVpreF immunization during pregnancy in Brazil against medically attended (inpatient and outpatient) respiratory syncytial virus-associated acute respiratory illness in infants. To achieve this, two multicenter, prospective, test-negative case-control studies will be conducted among infants with ARI: the TARSILA Inpatient Study, evaluating hospitalized infants and the TARSILA Outpatient Study, evaluating infants managed in outpatient settings.