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
Launched by SANOFI PASTEUR, A SANOFI COMPANY · Dec 2, 2022
Trial Information
Current as of January 14, 2025
Active, not recruiting
Keywords
ClinConnect Summary
Stage 1:
The duration of each participant's participation is 12 months for the Sentinel and Main Cohorts, 24 months overall for the subset of participants enrolled in the Booster Cohort.
Treatment Duration:
* Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 12 months post-vaccination.
* Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.
* Booster Cohort: 1 IM injection 12 months after the primary vaccination. Participants will be followed for 12 months after administration of the booster dose.
Stage 2:
The durat...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Sentinel Cohort Stage 1: Aged 18 to 50 years on the day of inclusion
- • Main Cohort Stage 1 and Stage 2: Aged 60 years or older on the day of inclusion
- Stage 1 and Stage 2:
- * Sentinel Cohort: A female participant is eligible to participate if she is not pregnant or breastfeeding and:
- • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile OR
- • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
- * Main and Booster Cohorts: A female participant is eligible to participate if she is not pregnant or breastfeeding and:
- • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile.
- • Able to attend all scheduled visits and to comply with all study procedures
- • Informed consent form has been signed and dated
- Exclusion Criteria:
- • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- • Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA COVID-19 vaccine
- • History of RSV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
- • Previous history of myocarditis, pericarditis, and/or myopericarditis
- • Thrombocytopenia or bleeding disorder, contraindicating IM injection based on investigator's judgment
- • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
- • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- • Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
- • Receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 4 weeks following any study intervention administration
- • Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
- • Previous vaccination against RSV with an investigational vaccine
- • Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- • Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- • Self-reported or documented human immunodeficiency virus (HIV) detected by any FDA-approved/validated test, hepatitis B virus surface antigen (HBsAg), hepatits B core antibodies (HBcAb), or hepatitis C virus antibodies (HCV Abs), or positive SARS-CoV-2 RT-PCR or antigen test
- • Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study
- • The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
About Sanofi Pasteur, A Sanofi Company
Sanofi Pasteur, a subsidiary of Sanofi, is a global leader in the development and production of vaccines. With a rich heritage in vaccine innovation, the company is dedicated to advancing public health by providing safe, effective, and accessible immunizations for a wide range of infectious diseases. Sanofi Pasteur invests significantly in research and development to address evolving health challenges and to enhance vaccine coverage worldwide. Committed to collaboration with health organizations and communities, the company strives to protect individuals and populations through its comprehensive portfolio of vaccines, contributing to the prevention of diseases and the promotion of healthier lives globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Medford, Oregon, United States
Municipio Del Distrito Central, , Honduras
San Pedro Sula, , Honduras
Hollywood, Florida, United States
North Charleston, South Carolina, United States
San Juan, , Puerto Rico
Miami, Florida, United States
Rincon, Georgia, United States
La Mesa, California, United States
Rolling Hills Estates, California, United States
San Diego, California, United States
Peoria, Illinois, United States
Beachwood, Ohio, United States
Beachwood, Ohio, United States
Austin, Texas, United States
Guayama, , Puerto Rico
Peoria, Arizona, United States
Phoenix, Arizona, United States
Thousand Oaks, California, United States
Cincinnati, Ohio, United States
East Greenwich, Rhode Island, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Botany, New South Wales, Australia
Camberwell, Victoria, Australia
Southport, , Australia
San Juan, , Puerto Rico
Mesa, Arizona, United States
River Forest, Illinois, United States
Lincoln, Nebraska, United States
Columbus, Ohio, United States
Norman, Oklahoma, United States
Round Rock, Texas, United States
West Jordan, Utah, United States
Carolina, , Puerto Rico
Guaynabo, , Puerto Rico
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Decatur, Georgia, United States
Austin, Texas, United States
Vestavia Hills, Alabama, United States
Rolling Hills Estates, California, United States
Medford, Oregon, United States
San Pedro Sula, , Honduras
Camberwell, Victoria, Australia
San Juan, , Puerto Rico
Hollywood, Florida, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mesa, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
La Mesa, California, United States
San Diego, California, United States
Thousand Oaks, California, United States
Miami, Florida, United States
Decatur, Georgia, United States
Rincon, Georgia, United States
Peoria, Illinois, United States
River Forest, Illinois, United States
Lincoln, Nebraska, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Norman, Oklahoma, United States
East Greenwich, Rhode Island, United States
North Charleston, South Carolina, United States
Austin, Texas, United States
Houston, Texas, United States
Round Rock, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
West Jordan, Utah, United States
Botany, New South Wales, Australia
Southport, , Australia
Municipio Del Distrito Central, , Honduras
Zaragoza, Veracruz, Mexico
Carolina, , Puerto Rico
Guayama, , Puerto Rico
Guaynabo, , Puerto Rico
San Juan, , Puerto Rico
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
Similar Trials