RSVpreF vaccine in adults: safety and immune response in India

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, double-blind, placebo-controlled Phase 3 trial conducted in India to evaluate the safety and immunogenicity of the RSVpreF vaccine in adults. Participants 18 and older, including those with stable chronic conditions, will be randomized to receive RSVpreF or placebo and followed for safety and immune response. Sites are located in Visakhapatnam and Bangalore. Eligibility includes ambulatory adults who live independently and have at least one chronic condition that elevates RSV risk, or are healthy adults aged 18–59 with stable disease. The study design emphasizes rigorous safety monitoring and antibody response measurements to determine vaccine performance in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.