Clinical Trials for Respiratory Syncytial Virus Infections

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Respiratory Syncytial Virus Infections from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 17
• Active, not recruiting: 9
• Completed: 14
• Other: 10

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT05655182 — A Study of BLB-201 RSV Vaccine in Infants and Children

This Phase 1/2a trial is a randomized, placebo-controlled trial to evaluate the safety, tolerability and immunogenicity of two ascending doses (10^6 PFU and 10^7 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type 5) administered in infants (8-24 months of age) and children (18-59 months of age) who may or may not have had prior respiratory syncytial virus (RSV) infection.

NCT06363370 — Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections

To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.

NCT06684379 — Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)

The purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of M2-macrophages and fat-derived Mesenchymal Stromal Cells (PRS CK STORM) in the modulation of the cytokine storm in participants with acute respiratory infection caused by SARS-Cov-2, influenza A, influenza B and resp…

NCT06866405 — A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose

This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.

NCT06955728 — A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.

Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too early and those born with heart and lung problems. It is the most common cause for children under 5 years old to be hospitalised. In 2019, there were about 33 million RSV-…

NCT07220109 — A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory syncytial virus (RSV) disease, in comparison with the immune response generated in older adults 60 YOA and above from the 219815 (RSV OA=ADJ-021; NCT06551181) study following a single dose of the RSVPreF3 OA vaccine. In add…

NCT07214571 — A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease

The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention within 72 hours of RSV symptom onset.

NCT06817889 — Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals

This phase II trial tests how well remdesivir works for treatment of respiratory syncytial virus (RSV) infection of the upper respiratory tract in patients receiving cellular or bispecific antibody therapy. Cellular or bispecific antibody therapies cause suppression of the immune system, making infections more frequent and reducing the body’s ability to fight the infections. RSV infections are …

NCT07653347 — Infant RSV Immunity Study

Respiratory Syncytial Virus (RSV) is a main global cause of respiratory illness and death in infants. Previous infant vaccine trials have failed to demonstrate protection. Moreover, RSV infection during early infancy, particularly in infants younger than 4 months of age, is associated with more severe disease, reduced immune protection, and an increased risk of developing childhood asthma. This…

NCT07658534 — A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.

Respiratory syncytial virus (RSV) is recognized worldwide as a significant pathogen causing lower respiratory tract infection in infants, the elderly, and immunocompromised patients, which may cause bronchiolitis or pneumonia, and affect the cardiovascular system, central nervous system and the renal system, resulting in hospitalization and death risks in children and also high-risk adults, par…

NCT07516418 — 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 stu…

NCT07633288 — A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses

A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection.

NCT07232706 — Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination

RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get better by themselves but babies and younger children can become very poorly. About 1 in 15 infants with confirmed RSV within the first 12 months of life will be hospitalised, and a very small proportion will be seriously il…

NCT07543380 — 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 t…

NCT07582796 — Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.

The primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the secondary objective being to assess its immunogenicity. The primary objectives of the phase II trial are to evaluate the immunogenicity and safety of the recombinant res…

NCT07640581 — Epidemiological Characteristics and Clinical Burden of RSV Infection in Children Under 24 Months in Ho Chi Minh City (2026-2028)

This is a prospective, observational, multicenter study employing continuous, convenience sampling, stratified by study site and by fortnightly interval, enrolling until the target sample sizes are achieved over the first epidemiological season (2026) and the second epidemiological season (2027). The study population includes children aged 0 to 24 months presenting to the outpatient or inpatien…

NCT07628049 — A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults

The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.

Active, Not Recruiting

NCT05443607 — 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 …

NCT05743881 — 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.

NCT06077968 — A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Disease

The main purpose of this study is to learn about the effectiveness of Pfizer’s ABRYSVO vaccine. This vaccine helps to prevent infections caused by Respiratory Syncytial Virus (RSV). RSV is a virus that can cause infections in the airways. These symptoms can be cold-like symptoms, but in some cases can lead to severe symptoms or hospitalization.

This study uses only healthcare data that are alr…

NCT06534892 — An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

The purpose of this study is:

• To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose,
• To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine,
• To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a d…

NCT06556147 — A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults

The main purposes of this study are to assess the safety, reactogenicity and immunogenicity of 4 dose levels of the bivalent combination Respiratory Syncytial Virus (RSV) / human Metapneumovirus (hMPV) vaccine candidate VXB-241 when administered as a single-dose regimen to healthy adults 60 to 83 years of age, and to assess the impact of revaccination approximately 1 year later.

NCT06647654 — 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 negat…

NCT06593210 — RSV Vaccine in Transplant Recipients

Adjuvant, non-live RSV vaccine will be administered to adult lung and allogeneic hematopoietic stem cell transplant recipients. The safety and immunogenicity of this intervention will be studied. Blood work will be collected before and after the intervention, to assess humoral and cellular immunity. Participants will be followed for adverse reaction, hospitalization, RSV breakthrough infection,…

NCT06984094 — Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults

This phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Parts 1 and 2) or Placebo (Part 3).

NCT07249320 — 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 medica…

Not Yet Recruiting

NCT07599449 — Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France

Every year in the fall and winter, numerous respiratory viruses (such as influenza viruses, SARS-CoV-2 (COVID-19), RSV, rhinovirus, and metapneumovirus) circulate in mainland France, causing acute respiratory infections (ARIs). These viruses can cause epidemics of varying severity, requiring close monitoring to determine their circulation levels and adapt public health measures accordingly. In …

NCT07578298 — 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 m…

NCT07618325 — 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.

NCT07673081 — 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

NCT07653100 — 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.

NCT07643688 — Expression of Inflammatory Markers in the Course of Acute Respiratory Viral Infections

Respiratory viral infections caused by influenza, respiratory syncytial virus (RSV), and SARS-CoV-2 remain major causes of morbidity, hospitalization, and mortality among older adults worldwide. Current antiviral therapies have limited effectiveness and generally require administration within the first 48 hours after symptom onset. Increasing evidence suggests that the programmed death receptor…

NCT07235397 — Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset

This study will use a retrospective cohort design and will be conducted within routinely collected national healthcare and statutory demographic datasets held by PHS and National Records of Scotland (NRS). As such, there will be no active enrollment of study participants, no direct contact with study participants, no collection of any primary data outside of the standard of care (SOC), and no r…

Completed Trials

NCT01224691 — TGF-(Beta) and Susceptibility to RSV

Background:

• Human respiratory syncytial virus (RSV) is a virus that causes respiratory tract infections, and is frequently responsible for hospital visits in infants and children. It can also trigger severe breathing problems for individuals who have asthma, but these infections are generally better tolerated in non-asthmatics. Some research suggests that lack of an efficient immune system r…

NCT01893554 — Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Children

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), an…

NCT04288921 — Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites

NCT04782336 — Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test

Collection of Nasal Swabs, Throat Swabs and Saliva Samples from patients presenting at their designated care or testing facility displaying symptoms of either Influenza, Respiratory Syncytial Virus (RSV), SARS-CoV-2 or those who have been in recent contact with SARS-CoV-2 positive patients. Collected samples will aid the development, calibration and performance evaluation of the LumiraDx POC Test.

NCT04938830 — Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).

NCT05268939 — Performance Evaluation of LumiraDx SARS-CoV-2, Flu A/B, and RSV Tests for COVID-19 Assessment

A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 & FLU A/B Test, and LumiraDx SARS-CoV-2 & RSV Test at Point of Care Testing Sites. Subjects presenting with symptoms suggestive of COVID-19 and/or Influenza and/or RSV will be consented and asked to donate swab sample(s) for testing in the device(s) under evaluation.

NCT05921903 — A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.

NCT06143046 — 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.

NCT06325657 — A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants

The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vacci…

NCT06551181 — A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older

The purpose of the current study is to evaluate the immune response of the RSVPreF3 OA investigational vaccine in older adults (OA) at least (>=) 60 years of age (YOA) in China compared to OA in the same age range to be enrolled from overseas countries that participated in the RSV OA=ADJ-006 (NCT04886596) study, since the vaccine efficacy against lower respiratory tract disease (LRTD) has been…

NCT06551506 — The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products

Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children <5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants…

NCT06614725 — A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)

The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of RSV-LRTD.

NCT06824207 — Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants

In June 2024, the German Standing Committee on Vaccination (STIKO) recommended the universal immunization of infants with nirsevimab during their first RSV season. Nirsevimab is a long-acting monoclonal antibody designed to provide passive immunity against RSV, significantly reducing the risk of severe RSV disease in infants. This recommendation marks the 2024/25 season as the first in which ni…

NCT07117487 — 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.

Other (Terminated)

NCT03699202 — Anti-RSV Study in Chinese Patients (ASCENT)

This is a randomised, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered AK0529 in Chinese adults with RSV infection.

NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

The goal of this clinical study was to learn more about the study drug, obeldesivir (ODV; GS-5245), and how safe and effective it was in treating nonhospitalized adults with acute respiratory syncytial virus (RSV) infection. The researchers wanted to see if obeldesivir can help participants’ symptoms get better faster.

The primary objectives of this study were to evaluate the efficacy of ODV i…

NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection

The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve.

The primary objectives of this study are: a) to evaluate the safety and tolerability of ODV in pediat…