This study is currently not recruiting participants.

Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older

Study on RSV Vaccine Candidate for Adults 60 and Older

Not Recruiting
60 years or above
All
Phase 2
4541 participants needed

Study Overview

The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV.

The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.

Study Details

Study duration per participant:

6 months.

Treatment Duration:

1 IM injection. Participants will be followed for approximately 6 months post- vaccination.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Respiratory Syncytial Virus Infection, Healthy Volunteers
  • Age: 60 years or above
  • Gender: All

Inclusion Criteria:

  • Aged 60 years or older on the day of inclusion
  • 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.

  • Participants with high-risk medical conditions who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion.

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

  • 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 an mRNA 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, contraindicating IM injection based on investigator's judgment
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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 in the 4 weeks preceding any study intervention administration or planned receipt of any 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 a licensed or investigational vaccine or planned receipt during study participation, of vaccination against RSV with a licensed or investigational vaccine other than the study vaccine
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months
  • 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 Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

This study investigates a vaccine candidate for Respiratory Syncytial Virus (RSV) in adults aged 60 years and older. This study aims to understand how well the vaccine works in preventing lower respiratory tract diseases caused by RSV.

The focus of this study is to evaluate the safety and effectiveness of the RSV vaccine candidate. Researchers are looking to see if the vaccine can help prevent illnesses related to RSV in older adults.

  • Who can participate: Adults aged 60 years and older can participate. Eligibility includes not being pregnant or breastfeeding and having no recent history of RSV-associated illness.
  • Study details: Participants will receive one injection and will be monitored for about 6 months. A placebo is an inactive substance that looks like the investigational vaccine but does not contain any medicine.
  • Study timelines: The study will last 6 months.
Updated on 02 Mar 2026. Study ID: NCT06251024