Trials
Search / Trial NCT05639894

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 February 05, 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.

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

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