Clinical trials: RSV Immunization
Respiratory Syncytial Virus Infections
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).
- Trial name
- BORLAND (NCT07235397)
- Testing
- ABRYSVO
- Volunteers
- 1 people
- Sponsor
- Pfizer
RSV Immunisation, Healthy Volunteers
A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
This study was a Phase III, parallel group, randomized, observer blind, placebo controlled, multi-national, multi-center, multi-arm study conducted in 42 healthy children enrolled at 6 months to <22 months of age.
- Trial name
- OPAL (NCT06705140)
- Testing
- Low Dose (LD) RSVt vaccine, Standard Dose (SD) RSVt vaccine, High Dose (HD) RSVt vaccine
- Where
- 3 sites in Honduras
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Syncytial Virus (RSV)
Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis
This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness…
- Trial name
- SUNRISE (NCT02282982)
- Volunteers
- 359 people
- Sponsor
- AbbVie
Respiratory Syncytial Virus Hospitalizations
An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants
Purpose of this study is to evaluate clinical, humanistic and health economic burden of Respiratory Syncytial Virus (RSV) in infants born 29 to 35 Weeks Gestational Age (wGA) hospitalized for RSV at up to 12 months of age.
- Trial name
- SENTINEL1 (NCT02273882)
- Where
- 44 sites in United States
- Volunteers
- 497 people
- Sponsor
- AstraZeneca
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus
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…
- Conditions
- Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease, Respiratory Tract Diseases
- Trial name
- STREETON (NCT07122661)
- Testing
- ABRYSVO
- Where
- Australia
- Volunteers
- 1 people
- Sponsor
- Pfizer
RSV Infection
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…
- Trial name
- NCT06866405
- Testing
- RSVpreF
- Where
- 97 sites in United States, Argentina and 2 more
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Pfizer
Respiratory Syncytial Virus (RSV) Infection, Respiratory Syncytial Virus Hospitalizations
The Impact of the 2025 Infant and Maternal Respiratory Syncytial Virus (RSV) Prevention Program on RSV-related Hospitalisations in the Australian Capital Territory
The goal of this observational study is to is to examine the impact of new RSV prevention medicines on the burden of RSV disease among young children.
- Conditions
- Respiratory Syncytial Virus (RSV) Infection, Respiratory Syncytial Virus Hospitalizations, Respiratory Syncytial Virus Immunization
- Trial name
- NCT07164430
- Where
- Australia
- Volunteers
- 2,792 people
- Sponsor
- Nicola Irwin
RSV Immunization
Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination.
RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months.
- Trial name
- PIPELINE-RSV (NCT07041190)
- Testing
- Abrysvo, Nirsevimab
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- PENTA Foundation
Respiratory Syncytial Virus Infections, Severe Acute Respiratory Infection
Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá
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…
- Conditions
- Respiratory Syncytial Virus Infections, Severe Acute Respiratory Infection, Bronchiolitis, Viral, Viral Respiratory Tract Infection
- Trial name
- NCT07279298
- Testing
- RSVpreF vaccine (Abrysvo) and Nirsevimab (Beyfortus) or unexposed
- Where
- Colombia
- Volunteers
- 1,097 people
- Sponsor
- Bogotá District Health Secretariat
Respiratory Syncytial Virus (RSV), Maternal Vaccine Exposure
Respiratory Syncytial Virus (RSV) and Vaccination in Pregnancy
Respiratory Syncytial Virus (RSV) is the leading cause of chest infections (pneumonia and bronchiolitis) in young children, and is a major cause of admission to hospital and childhood death worldwide.
- Conditions
- Respiratory Syncytial Virus (RSV), Maternal Vaccine Exposure, Attitude
- Trial name
- NCT03096574
- Testing
- Questionnaire
- Where
- 4 sites in United Kingdom
- Volunteers
- 1,025 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
RSV Immunization
Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India
The purpose of this study is to describe the safety and efficacy outcomes associated with the use of nirsevimab, administered as per routine clinical practice, in neonates and infants aged 0 to 12 months born during or entering…
- Trial name
- NCT07109297
- Testing
- Nirsevimab
- Where
- 7 sites in India
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Sanofi
Bronchiolitis
Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns
Bronchiolitis is a lower respiratory tract infection, extremely common in pediatrics, and potentially serious. Bronchiolitis affects nearly 30% of infants under 2 years old each year, representing approximately 480,000 cases…
- Trial name
- Abrystus (NCT07251972)
- Testing
- to compare vaccine and monoclonal antibody
- Where
- France
- Volunteers
- 1,137 people
- Sponsor
- Jean-Michel HASCOET
RSV Immunization
Artificial Intelligence-assisted Primary Care for RSV Prevention (AIPC-RSV) in China
The goal of this clinical trial is to evaluate whether an AI-assisted primary care intervention for parents can increase RSV monoclonal antibody (mAb) uptake among infants, and to assess the cost-effectiveness and potential for…
- Trial name
- NCT07856290
- Testing
- RSV AI-assisted primary care intervention
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Fudan University
Respiratory Syncytial Virus (RSV)
A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for…
- Trial name
- Synagis Russia (NCT02968173)
- Testing
- Palivizumab
- Volunteers
- 50 people
- Sponsor
- AbbVie
Respiratory Syncytial Virus Infection
Prevention of RSV Infections in Bone Marrow Transplant Recipients
Respiratory Syncytial Virus (RSV) infections are very common and widespread. By age 5, virtually everyone has been infected and developed antibodies against some strain of the virus.
- Trial name
- NCT00001903
- Testing
- RSV Polyclonal Immunoglobulin
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Bronchiolitis, Respiratory Syncytial Virus (RSV)
Evaluation in Practice of the Impact of NIrsevimab on EmeRgency Use for BRONCHIOlitis
In July 2023, the Food and Drug Administration approved nirsevimab (Beyfortus®), a long-acting monoclonal antibody, for passive immunization to prevent RSV-associated lower respiratory tract infection (Bronchiolitis) among…
- Conditions
- Bronchiolitis, Respiratory Syncytial Virus (RSV), Immunization; Infection
- Trial name
- EPINIR-BRONC (NCT06185647)
- Testing
- No intervention. Observational retrospective study
- Where
- France
- Volunteers
- 4,924 people
- Sponsor
- Hôpital Armand Trousseau
Respiratory Syncytial Virus (RSV), Respiratory Infection Virus
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…
- Trial name
- THRIVE (NCT07578298)
- Testing
- Nirsevimab (RSV-specific monoclonal antibody)
- Where
- Australia
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Menzies School of Health Research
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Syncytial Virus (RSV), Maternal Immunization
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…
- Conditions
- Respiratory Syncytial Virus (RSV), Maternal Immunization, Acute Respiratory Illness (ARI), Lower Respiratory Tract Disease
- Trial name
- TARSILA (NCT07445763)
- Testing
- respiratory syncytial virus bivalent prefusion F vaccine
- Where
- 8 sites in Brazil
- Volunteers
- 5,000 people
- Sponsor
- Inova Medical
Respiratory Syncytial Virus Infections
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study.
- Trial name
- NCT05705440
- Testing
- RSVPreF3 vaccine, Control
- Where
- 138 sites in United States, Argentina and 21 more
- Volunteers
- 3,855 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline