A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF

Inclusion Criteria16

• Participants ≥18 years of age at Visit 1.
• Participants who are ambulatory and live independently in the community.
• Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
• Applicable to participants 18 through 59 years of age: Participants who are healthy or have stable preexisting diseases. These participants are considered at high risk of RSV disease by having at least 1 reportable stable chronic medical condition(s) that belongs to 1 or more of the following:
• Chronic heart disease (ie, coronary artery disease, heart failure, or congenital heart disease)
• Chronic lung disease (ie, COPD, emphysema, asthma, interstitial lung disease, or cystic fibrosis)
• Nongestational diabetes mellitus type 1 or type 2
• Severe obesity (body mass index \[BMI\] ≥40 kg/m2)
• Chronic liver disease (ie, cirrhosis)
• Chronic kidney disease (not including end-stage renal disease with or without dialysis)
• Chronic neurological disease that causes impaired airway clearance or respiratory muscle weakness (ie, poststroke dysphagia, amyotrophic lateral sclerosis, or muscular dystrophy)
• Chronic hematologic disease (ie, sickle cell disease or thalassemia)
• Note: A chronic medical condition for this study is defined as:
• Duration ≥6 months.
• Requires regular medical follow-up or ongoing prescribed medication or hospitalization in the previous year.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.