Respiratory Syncytial Virus Infections

15

Review clinical trials related to Respiratory Syncytial Virus Infections. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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 requirement for informed consent. This study design was chosen due to several advantages, over other possible designs, including the ability to evaluate incidence of study outcomes in exposed and unexposed infants, ability to follow infants longitudinally to evaluate study outcomes through 12 months of age, and ability to evaluate all-cause outcomes. Study endpoints, including RSV-associated LRTD hospitalization and RSV-associated hospitalization, 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 through 6 months of age, with later analysis from birth through 12 months as the infants reach this age threshold and their data become available.

Participants needed: 1
Trial details
Age: 0-12Biological sex: AllType: ObservationalSponsor: PfizerUpdated: Jul 1, 2026
Eligibility criteria

Live birth in Scotland from 1st September 2024 to 28th February 2026 [+3]

Status: Recruiting

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.

Participants needed: 322
Trial details
Phase: Phase 3Age: 2-2Biological sex: AllType: InterventionalSponsor: Kexing Biopharm Co., Ltd.Updated: Jul 1, 2026Locations: 1
Eligibility criteria

2 months ≤ age ≤ 2 years of age (including the correction age of premature babie...

There is a history of drug allergies (interferon products, related solutions for... [+16]

Status: Recruiting

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.

Participants needed: 192
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: ShionogiUpdated: Jun 23, 2026Locations: 77
Eligibility criteria

Participants who have new onset or worsening (if present chronically) of at leas... [+5]

Hospitalized or expected to be hospitalized within 24 hours of screening. [+9]

Status: Recruiting

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, particularly the elderly. The purpose of this study is to evaluate the efficacy of Ziresovir (AK0529) compared to placebo with respect to the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms.

Participants needed: 290
Trial details
Phase: Phase 2, Phase 3Age: 18-85Biological sex: AllType: InterventionalSponsor: Shanghai Ark Biopharmaceutical Co., Ltd.Updated: Jun 22, 2026Locations: 9
Eligibility criteria

Aged 18-85 years (inclusive), regardless of gender. [+4]

Diagnosed with influenza or COVID-19 infection within 7 days prior to providing... [+7]

Status: Recruiting

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 respiratory syncytial virus (RSV) in need for oxygen therapy. The main questions it aims to answer are: * Are both doses of PRS CK STORM (dose A and dose B) safe as an intravenous drug to modulate inflammatory processes, such as the cytokine storm in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV? * Are both doses of PRS CK STORM (dose A and dose B) effective as an intravenous drug to modulate SIRS-associated cytokine storm caused by SARS-Cov-2, influenza A, influenza B and RSV compared to the control group? * What are the anti-inflammatory and pro-inflammatory cytokine profiles after treatment with two different doses of PRS CK STORM in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV? Researchers will compare both doses of PRS CK STORM with the control group to test whether the anti-inflammatory action of PRS CK STORM is safe and effective in modulating the cytokine storm for the treatment of SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV. In addition, the anti-inflammatory and pro-inflammatory cytokine profiles after treatment PRS CK STORM compared to placebo group in these participants will be also studied.

Participants needed: 50
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: PEACHES BIOTECHUpdated: Jun 10, 2026Locations: 3
Eligibility criteria

Signed informed consent by the participant or legal representative prior to the... [+8]

Failure to perform screening or baseline examinations. [+17]

Status: Recruiting

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.

Participants needed: 137
Trial details
Phase: Phase 1, Phase 2Age: 6-5Biological sex: AllType: InterventionalSponsor: Blue Lake Biotechnology Inc.Updated: Jun 3, 2026Locations: 15
Eligibility criteria

Not listed

Status: Recruiting

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 addition, the safety and reactogenicity of the vaccine will also be assessed.

Participants needed: 750
Trial details
Phase: Phase 3Age: 18-59Biological sex: AllType: InterventionalSponsor: GlaxoSmithKlineUpdated: May 27, 2026Locations: 15
Eligibility criteria

Participants who, in the opinion of the investigator, can and will comply with t... [+12]

Any confirmed or suspected immunosuppressive or immunodeficient condition result... [+16]

Status: Recruiting

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 respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) with different adjuvant ratios in adults aged 60 years and older, with the secondary objective being to evaluate the persistence of immune responses.

Participants needed: 470
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Ab&B Bio-tech Co., Ltd.JSUpdated: May 27, 2026Locations: 1
Eligibility criteria

Males or females aged 18 years and older at the time of enrollment (aged 18 year... [+5]

Clinically significant laboratory abnormalities that, in the investigator's comp... [+20]

Status: Not yet recruiting

A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults

The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults.

Participants needed: 200
Trial details
Phase: Phase 1Age: 18-79Biological sex: AllType: InterventionalSponsor: Shenzhen Shenxin Biotechnology Co., LtdUpdated: Apr 13, 2026
Eligibility criteria

Healthy male or female participants aged ≥18 to 59 years of age (Part 1) or ≥ 60... [+5]

Pregnant or lactating at Screening or prior to vaccination or planning to become... [+20]

Status: Recruiting

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.

Participants needed: 184
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: GlaxoSmithKlineUpdated: Mar 6, 2026Locations: 37
Eligibility criteria

Participants of the RSV OA=ADJ-023 study from the Per Protocol Set (Visit 3 for... [+8]

Any history of dementia or any medical condition that moderately or severely imp... [+33]

Status: Recruiting

Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children

The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway.

Participants needed: 370
Trial details
Phase: Phase 3Age: 3-2Biological sex: AllType: InterventionalSponsor: University of Alabama at BirminghamUpdated: Feb 9, 2026Locations: 15
Eligibility criteria

Admission to the pediatric ICU with a confirmed diagnosis of RSV infection. RSV... [+4]

AZM use within 7 days of ICU admission; [+7]

Status: Not yet recruiting

Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV

This study aims to evaluate the real-world effectiveness of two preventive immunization strategies against Respiratory Syncytial Virus (RSV)-associated severe acute respiratory infection in infants less than six months of age in Bogotá, Colombia. The strategies include maternal vaccination with RSVpreF administered between 28 and 36 weeks of gestation and neonatal immunization with nirsevimab for infants born to mothers who did not receive RSVpreF during pregnancy. Using a test-negative case-control design embedded in the city's sentinel surveillance system, infants hospitalized for severe respiratory infection will be systematically tested for RSV. Comparative vaccine effectiveness will be estimated to determine the impact of maternal RSV vaccination and neonatal monoclonal antibody immunization on RSV-associated hospitalizations, intensive care admissions, and mortality. The study will generate real-world evidence to inform local and regional public health decisions and guide the implementation of cost-effective hybrid immunization strategies against RSV in middle-income settings.

Participants needed: 1,097
Trial details
Age: 1-180Biological sex: AllType: ObservationalSponsor: Bogotá District Health SecretariatUpdated: Dec 12, 2025
Eligibility criteria

Age: Infants younger than 6 months at the time of hospital admission. [+4]

Prematurity: Infants born at ≤32 weeks of gestation. [+8]

Status: Recruiting

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

This observational, prospective, multicenter study aims to estimate the proportion of RSV infection in adults aged 60 years and older hospitalized due to acute respiratory infections or exacerbation of cardiopulmonary disease.

Participants needed: 1,000
Trial details
Age: 60+Biological sex: AllType: ObservationalSponsor: Tam Anh Research InstituteUpdated: Nov 20, 2025Locations: 1
Eligibility criteria

Individuals ≥ 60 years old at the time of screening (calculated from the date of... [+4]

Symptom onset > 6 days prior to screening date [+3]

Status: Recruiting

Identification and Clinical Validation of Biomarkers Associated With Clinical Severity in Adults Infected With RSV

A short description, 5000 characters Intro: Respiratory Syncytial Virus (RSV) is a frequent, ubiquitous agent of respiratory viral infections. It is the leading viral cause of lower respiratory tract infection (LRTI) in infants and also causes significant morbidity and mortality in adults, especially in the elderly, in patients with cardiorespiratory comorbidities \[e.g., patients with Chronic Obstructive Pulmonary Disease (COPD) and/or heart failure\], and in immunocompromised patients. Clinical phenotyping of RSV respiratory infections has shown that the occurrence of LRTI in RSV-infected patients is associated with the need for ventilatory support and an increased risk of mortality. Virological data also suggest that there is a relationship between high nasopharyngeal viral replication levels and a poor prognosis, although these data have not been confirmed in other studies. Beyond viral load, the impact of viral subtypes on the severity of RSV infection is controversial. Few data have explored the prognostic value of genetic diversity (i.e., role of RSV variants, mutations occurring during clinical course) in RSV-infected adult patients with acute respiratory failure. Objective: The main goal of the present study is to identify and validate biomarkers associated with RSV severity in adults infected with RSV that will be useful to guide treatment decisions in the future. This study will additionally characterize the thus far unknown genetic diversity of RSV in hospitalized adults with severe and mild infections, in order to anticipate virological escape mechanisms from current and future treatments. Method: This is a prospective multicenter cohort study of patients with RSV infection admitted to the hospital. These patients will be followed-up for 28 days. Nasopharyngeal samples will be obtained sequentially (i.e., at day 0, day 3-4, day 5-7, and day 14 of inclusion) for virological and transcriptomic analyses. Blood samples will also be collected at day 0 (EDTA tubes and Paxgene tubes) for peripheral transcriptomic analyses and plasma banking. The 100 first patients included in the study will be allocated to the development cohort and the last 100 patients will be allocated to the validation cohort.

Participants needed: 133
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Jan 9, 2024Locations: 1
Eligibility criteria

Age > 18 years [+3]

Co-infection with other respiratory viruses [+11]

Status: Not yet recruiting

Epidemiology and Household Transmission of Streptococcus Pneumoniae and Respiratory Syncytial Virus

This household-based prospective cohort study aims to stablish the household transmission of Respiratory syncytial virus and S. pneumoniae especially in the elderly and infants/children as well as inter-relationship between S. pneumoniae and Respiratory syncytial virus.

Participants needed: 240
Trial details
Biological sex: AllType: ObservationalSponsor: Mackay Memorial HospitalUpdated: Aug 24, 2021Duration: 2 Years
Eligibility criteria

Indicator case: Babies under 5 months of age were born in Mackay Children's Hosp... [+2]

Babies older than 5 months [+5]