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New RSV vaccine aims to shield adults from severe respiratory infection

NCT ID NCT07653100

Vaccine Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This study tests an experimental vaccine called RSVpreF in adults to see if it is safe and triggers a strong immune response against respiratory syncytial virus (RSV). Around 540 adults in India will receive either the vaccine or a placebo. Researchers will monitor for side effects and measure antibody levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RSVpreF vaccine
What this could lead to
If successful, this vaccine could help protect adults from severe RSV infections, reducing hospitalizations and serious respiratory illness.
What could go wrong
This is a phase 3 trial focused on safety and immune response, not yet proven to prevent disease. Side effects like injection-site reactions or fever are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 540 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory syncytial virus (RSV)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aakash Healthcare Private Limited

    RECRUITING

    Dwarka, National Capital Territory of Delhi, 110075, India

  • All India Institute Of Medical Sciences

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110029, India

  • BGS Global Institute of Medical Sciences (BGSGIMS)

    RECRUITING

    Bangalore, Karnataka, 560060, India

  • Belagavi Institute of Medical Sciences - Belagavi

    RECRUITING

    Belagavi, Karnataka, 590001, India

  • Chettinad Hospital and Research Institute

    RECRUITING

    Kelambākkam, Tamil Nadu, 603103, India

  • Institute of Post Graduate Medical Education & Research, SSKM Hospital

    RECRUITING

    Kolkata, West Bengal, 700020, India

  • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

    RECRUITING

    Kolkata, West Bengal, 700020, India

  • King George Hospital

    RECRUITING

    Visakhapatnam, Andhra Pradesh, 530002, India

  • Maharaja Agrasen Superspeciality Hospital

    RECRUITING

    Jaipur, Rajasthan, 302039, India

  • Radhakrishna Multispeciality Hospital and IVF Center

    RECRUITING

    Bangalore, Karnataka, 560085, India

  • SRM Medical College Hospital and Research Centre - Kattankulathur

    RECRUITING

    Chengalpattu, Tamil Nadu, 603203, India

  • Sir Ganga Ram Hospital

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110060, India

  • Suyog Hospital

    RECRUITING

    Nashik, Maharashtra, 422003, India

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