Clinical trials: RSV Immunisation
Infections, Respiratory Syncytial Virus
Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines
The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.
- Trial name
- NCT01905215
- Testing
- RSV vaccine GSK3003892A (formulation 1), RSV vaccine GSK3003893A (formulation 2), RSV vaccine GSK3003895A (formulation 3)
- Where
- 3 sites in Canada
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.
The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant…
- Trial name
- NCT02247726
- Testing
- RSV F vaccine (0.5mL injection)
- Where
- 7 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novavax
Healthy Volunteers, Influenza Vaccination
A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.
The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus /…
- Conditions
- Healthy Volunteers, Influenza Vaccination, Respiratory Syncytial Virus Vaccination, Parainfluenza Vaccination
- Trial name
- NCT06850051
- Testing
- TIV-HA Vaccine formulation 1 at low dose, TIV-HA formulation 1 at high dose, TIV-HA formulation 2 at low dose
- Where
- 6 sites in Australia
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Sanofi
RSV Immunization
An Observational Study to Assess Nirsevimab Immunization Rates in Eligible Infants During Their First RSV Season in the Czechia
The primary objective of this study is to determine the nirsevimab immunization rate in eligible infants in their first RSV-season in Czechia. The study will focus on: 1.
- Trial name
- NCT07634692
- Testing
- Nirsevimab Respiratory Syncytial Virus monoclonal antibody
- Where
- Czechia
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- Sanofi
Respiratory Syncytial Virus Immunization
Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants
In June 2024, the German Standing Committee on Vaccination (STIKO) recommended the universal immunization of infants with nirsevimab during their first RSV season.
- Trial name
- Vakzimeter RSV (NCT06824207)
- Where
- Germany
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Syncytial Virus Immunization
Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49…
- Trial name
- NCT07071558
- Testing
- RSV vaccine formulation 1 dose, RSV vaccine formulation 2 dose, RSV vaccine formulation 3 dose
- Where
- 6 sites in Australia
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
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
Healthy
A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older
The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years.
- Trial name
- NCT04354480
- Testing
- RSV Vaccine
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
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
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 (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), 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
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