A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF
A PHASE 3 STUDY IN INDIA TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
- Respiratory Syncytial Virus (RSV)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 540
- Started
- 22 June 2026
- Main results due
- 25 January 2027
- Study sites
- 13
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(13)
King George Hospital
Visakhapatnam, Andhra Pradesh, India
Recruiting
BGS Global Institute of Medical Sciences (BGSGIMS)
Bangalore, Karnataka, India
Recruiting
Radhakrishna Multispeciality Hospital and IVF Center
Bangalore, Karnataka, India
Recruiting
Belagavi Institute of Medical Sciences - Belagavi
Belagavi, Karnataka, India
Recruiting
Suyog Hospital
Nashik, Maharashtra, India
Recruiting
Bharati Vidyapeeth {Deemed to be University) Medical College Hospital & Research Centre
Pune, Maharashtra, India
Recruiting
Aakash Healthcare Private Limited
Dwarka, National Capital Territory of Delhi, India
Recruiting
All India Institute Of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Recruiting
Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, India
Recruiting
SRM Medical College Hospital and Research Centre - Kattankulathur
Chengalpattu, Tamil Nadu, India
Recruiting
Chettinad Hospital and Research Institute
Kelambākkam, Tamil Nadu, India
Recruiting
Institute of Post Graduate Medical Education & Research, SSKM Hospital
Kolkata, West Bengal, India
Recruiting
Showing 13 of 13 sites. 13 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07653100. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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