The purpose of this phase 3 multicenter, double-blinded, placebo-controlled study in India is to learn about the safety and immunogenicity of RSVpreF in adults.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
* Prior history of any subtype of Guillain-Barré syndrome of any etiology.
* Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
* Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study.
Primary outcome measure(s)
Proportion of participants reporting local reactions within 7 days following investigational product administration — Within 7 days Describe local reactions following investigational product administration
Percentage of participants reporting systemic events within 7 days following investigational product administration — Within 7 days Describe systemic events following investigational product administration
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration — 1 month after vaccination Describe AEs occurring through 1 month following administration of investigational product
Percentage of participants reporting serious adverse events (SAEs) throughout the study — 3 months after vaccination Describe SAEs through 3 months following administration of investigational product
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT) — Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR) — Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as seroresponse rate — 1 month after vaccination
Trial sites (13)
Facility
City
Region
Status
King George Hospital
Visakhapatnam
Andhra Pradesh
Recruiting
BGS Global Institute of Medical Sciences (BGSGIMS)
Bangalore
Karnataka
Recruiting
Radhakrishna Multispeciality Hospital and IVF Center
Bangalore
Karnataka
Recruiting
Belagavi Institute of Medical Sciences - Belagavi
Belagavi
Karnataka
Recruiting
Suyog Hospital
Nashik
Maharashtra
Recruiting
Aakash Healthcare Private Limited
Dwarka
National Capital Territory of Delhi
Recruiting
All India Institute Of Medical Sciences
New Delhi
National Capital Territory of Delhi
Recruiting
Sir Ganga Ram Hospital
New Delhi
National Capital Territory of Delhi
Recruiting
Maharaja Agrasen Superspeciality Hospital
Jaipur
Rajasthan
Recruiting
SRM Medical College Hospital and Research Centre - Kattankulathur
Chengalpattu
Tamil Nadu
Recruiting
Chettinad Hospital and Research Institute
Kelambākkam
Tamil Nadu
Recruiting
Institute of Post Graduate Medical Education & Research, SSKM Hospital
Kolkata
West Bengal
Recruiting
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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