Clinical trials: RSV Immunization
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
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
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 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
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
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
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
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 (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
Prematurity, RSV
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.
Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination rate against influenza are low in spite of national programs.
- Conditions
- Prematurity, RSV, Influenza, Upper Respiratory Tract Infection
- Trial name
- NCT01985620
- Testing
- Educational intervention
- Where
- Israel
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
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