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.
Description
Study duration per participant:
6 months.
Treatment Duration:
1 IM injection. Participants will be followed for approximately 6 months post- vaccination.
Eligibility
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.