Clinical trials: Respiratory Syncytial Virus Immunization
Respiratory Syncytial Virus, Respiratory Tract Diseases
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…
- Trial name
- BERNI (NCT06647654)
- Testing
- ABRYSVO
- Where
- Argentina
- Volunteers
- 1 people
- Sponsor
- Pfizer
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 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
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 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)
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
RSV Immunisation
Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to < 22 months of age.
- Trial name
- PEARL (NCT06252285)
- Testing
- RSVt Vaccine
- Where
- 130 sites in United States, Argentina and 14 more
- Volunteers
- 6,300 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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)
RSV Infection
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
The purpose of this study is to continue evaluating how well the RSV vaccines work as they are currently being used in routine clinical practice.
- Trial name
- NCT06172660
- Testing
- Nirsevimab
- Where
- United States
- Volunteers
- 3,750 people
- Sponsor
- Yale University
RSV Immunization
Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12…
- Trial name
- CORAL (NCT06397768)
- Testing
- RSVt vaccine, Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine, Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine
- Where
- 72 sites in United States, Mexico and 1 more
- Volunteers
- 2,226 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
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
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 Infection
Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
A longitudinal observational study based on routinely collected data on hospital and health care use for RSV infections will be undertaken.
- Trial name
- NIRSE-GAL (NCT06180993)
- Testing
- Nirsevimab
- Where
- Spain
- Volunteers
- 42,000 people
- Sponsor
- Federico Martinón Torres
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
RSV Infections, RSV Immunisation
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…
- Conditions
- RSV Infections, RSV Immunisation, Preterm Labour
- Trial name
- NCT06955728
- Testing
- Vaccine
- Where
- 11 sites in Ghana, Kenya and 2 more
- Volunteers
- 13,000 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
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
Fever, Adverse Event Following Immunisation
Safety of RSV Preventive Monoclonal Antibody
This is a prospective, randomized, open-label clinical trial to evaluate the safety of administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other routine childhood vaccines given simultaneously…
- Trial name
- NCT07158814
- Testing
- Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
- Where
- 6 sites in United States
- Volunteers
- 524 people, healthy volunteers welcome
- Sponsor
- Duke University
Respiratory Syncytial Virus (RSV)
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…
- Trial name
- NCT07249320
- Testing
- ABRYSVO
- Where
- United States
- 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