Clinical trials: RSV Immunisation
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), 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
- Volunteers
- 5,000 people
- Sponsor
- Inova Medical
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 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
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
RSV Immunisation Status in Queensland (Australia)
The primary objective of this study is to determine the nirsevimab immunisation rate in eligible infants (according to Queensland Paediatric Respiratory Syncytial Virus Prevention Program recommendation) in Queensland, Australia.
- Trial name
- NCT07615192
- Testing
- Nirsevimab Respiratory Syncytial Virus monoclonal antibody
- Where
- Australia
- Volunteers
- 1,113 people, healthy volunteers welcome
- Sponsor
- Sanofi
Vaccine Hesitancy, Vaccine Refusal
Vaccine Confidence Study Among Historically Marginalized Racial and Ethnic Groups
Achieving optimal vaccination rates is vital for protecting the health and well-being of all individuals. This specific study focuses on the MMR and RSV vaccines in pregnancy and early childhood, which have been shown to reduce…
- Trial name
- NCT06639386
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boston Medical Center
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
The goal of this clinical trial is to learn if the RSV vaccine (protects against respiratory syncytial virus) and Tdap vaccine (protects against pertussis) are most effective in pregnant individuals when taken together at the…
- Conditions
- RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Pregnancy, Healthy
- Trial name
- CosTaR (NCT07097012)
- Testing
- Tdap Vaccine Administration, RSV Vaccine
- Where
- 4 sites in Canada
- Volunteers
- 60 people
- Sponsor
- Canadian Immunization Research Network
Respiratory Syncytial Virus Immunization
Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
Brief Summary of Stage 1: The purpose of Stage 1 (Phase I/IIa) was to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate…
- Trial name
- NCT05639894
- Testing
- RSV vaccine candidate
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 865 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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), 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
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
Vaccination, Respiratory Syncytial Virus (RSV)
Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients
The purpose of this study is to compare the immunogenicity and safety of respiratory syncytial virus (RSV) vaccination between lung transplant recipients and immunocompetent adults and to provide evidence to guide RSV vaccination…
- Conditions
- Vaccination, Respiratory Syncytial Virus (RSV), Lung Transplant Recipient
- Trial name
- NCT07895394
- Testing
- RSVPreF3 vaccination
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Seoul National University Hospital
Vaccine Immune Response, Haemodialysis Patients
Vaccination Response Modulation With a Targeted Rapamycin Protocol Study
This study will investigate dialysis recipients' responses to important vaccines. Research suggests that a medication commonly used by transplant recipients may improve vaccine responses.
- Conditions
- Vaccine Immune Response, Haemodialysis Patients, Older Adults
- Trial name
- VON TRAPP (NCT07587801)
- Testing
- Sirolimus (RAPAMUNE), Influenza vaccine (Sequiris Fluad Quad), RSV vaccine (Pfizer Abrysvo)
- Where
- 3 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Central Adelaide Local Health Network Incorporated
Respiratory Syncytial Virus (RSV), Infectious Disease
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, the prevention of Respiratory Syncytial Virus (RSV) infection and diseases.
- Trial name
- NCT06564194
- Testing
- JCXH-108
- Where
- 3 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Immorna Biotherapeutics, Inc.
Respiratory Syncytial Virus Infections
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…
- Trial name
- RSV OA=ADJ=012 (NCT06534892)
- Testing
- RSVPreF3 OA vaccine
- Where
- 251 sites in United States, Australia and 15 more
- Volunteers
- 10,212 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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
Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults
In this randomised, placebo-controlled, double-blind Phase 2a study, healthy male and female participants 18-50 years of age will be given an investigational RSV vaccine (RSVpreF) and challenged with RSV one month later.
- Trial name
- NCT04785612
- Testing
- RSVPreF
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hvivo
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated women
- Trial name
- NCT03191383
- Testing
- RSV vaccine (GSK3003891A) formulation 1, RSV vaccine (GSK3003891A) formulation 2, RSV vaccine (GSK3003891A) formulation 3
- Where
- 12 sites in United States, Finland and 1 more
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline