Updated June 2026 · ClinicalTrials.gov
Phase 3 Respiratory Syncytial Virus (rsv) Trials
12 Phase 3 trials for Respiratory Syncytial Virus (rsv), the final stage before a treatment can be submitted for FDA approval.
12 Phase 3 clinical trials for Respiratory Syncytial Virus (rsv) are registered on ClinicalTrials.gov. Phase 3 is the final stage of testing before a treatment can be submitted for FDA approval, and the trials below come directly from the federal registry. Always talk to your doctor before contacting a study site.
What Phase 3 Means for Respiratory Syncytial Virus (rsv)
Phase 3 trials are the largest and most expensive stage of clinical research before potential FDA approval. For Respiratory Syncytial Virus (rsv), a Phase 3 protocol typically enrolls several hundred to several thousand patients across many medical centers, randomizes participants between the investigational treatment and either a placebo or current standard of care (where ethically appropriate), and tracks them for months or years to confirm that the treatment is both effective and safe in a real-world patient population.
12 Phase 3 trials for Respiratory Syncytial Virus (rsv) are currently registered. Conditions in this range often have a focused research agenda with a small number of late-stage candidates, frequently targeting a specific subpopulation or stage of the disease.
Pfizer (2), Simcere Pharmaceutical Co., Ltd (1), University of Witwatersrand, South Africa (1) lead the Phase 3 Respiratory Syncytial Virus (rsv) sponsor list. The blend of industry, academic, and government sponsors on a condition's Phase 3 list is a useful signal of how broadly the research community is engaged with the disease.
Phase 3 Respiratory Syncytial Virus (rsv) Trials on ClinicalTrials.gov
A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
This is a randomized, double-blind, placebo-controlled, parallel-group trial conducted in infants and young children aged 1 to 36 months with RSV infection. A total of 498...
A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower...
Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death -...
A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a...
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose...
Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract...
To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to...
The study will evaluate the immune response of the RSVPreF3 OA investigational vaccine in Chinese adults 18 to 59 years of age (YOA) who are at increased risk of respiratory...
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be...
Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell)
This study will evaluate the efficacy of the Recombinant RSV vaccine(CHO cell) vaccine in preventing lower respiratory tract diseases(LRTD) caused by RSV in adults≥ 60 years of...
Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination
RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get...
A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants
Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of...
A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.
The purpose of the study is to learn about the immune response after a RSVpreF vaccination. This study is being conducted in Japan. RSV is a common virus that can cause infections...
Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis
The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main...
RSV Immunogenicity Study in the Elderly (RISE)
Respiratory syncytial virus (RSV) is a common cause of respiratory tract infections leading to hospitalizations in infants and in elderly. Arexvy is an approved vaccine for the...
What Participation Looks Like
Phase 3 trials for Respiratory Syncytial Virus (rsv) typically enroll several hundred to several thousand participants across multiple sites. Participation involves a screening visit to confirm eligibility, randomization to either the investigational treatment or a comparator (often the current standard of care), regular study visits over months or years, and follow-up after the active treatment period. The protocols, time commitments, and visit schedules differ from trial to trial — read the per-trial page for the specifics before discussing participation with your doctor.
Each trial begins with informed consent and a screening visit, where the study team confirms eligibility against the inclusion and exclusion criteria. Randomization assigns participants to either the investigational treatment or a comparator. Standard-of-care portions of the protocol are typically billed to insurance; trial-specific procedures (extra imaging, biopsies, lab draws beyond standard care) are usually covered by the sponsor. Read each trial\'s detailed page for its specific time commitment and visit schedule.
Authoritative Resources for Respiratory Syncytial Virus (rsv) Trials
Verify any individual trial directly on ClinicalTrials.gov. For the federal context on how Phase 3 results feed into approval decisions, see the FDA drug approval process. For oncology-specific trial resources, the National Cancer Institute publishes patient-oriented overviews. For trials registered outside the U.S., the WHO ICTRP aggregates registries from around the world.
Frequently Asked Questions
What is a Phase 3 Respiratory Syncytial Virus (rsv) trial?
A Phase 3 trial is the final stage of clinical testing before a treatment can be submitted to the FDA for approval. For Respiratory Syncytial Virus (rsv), Phase 3 studies typically enroll hundreds to thousands of patients across multiple medical centers, comparing the new treatment to the current standard of care or a placebo (where ethically appropriate). The goal is to confirm efficacy, monitor side effects in a larger population, and generate the evidence the FDA needs to make an approval decision.
How many Phase 3 Respiratory Syncytial Virus (rsv) trials are recruiting?
12 Phase 3 trials for Respiratory Syncytial Virus (rsv) are currently registered on ClinicalTrials.gov. Recruitment status varies by trial — some are actively enrolling, some have closed enrollment but are still in the active treatment phase, and some are completing follow-up. Click any trial below to see its current status, eligibility criteria, and contact information.
Who can participate in a Phase 3 Respiratory Syncytial Virus (rsv) trial?
Phase 3 eligibility depends entirely on the specific trial protocol. Each trial sets its own inclusion criteria (typically a confirmed diagnosis, certain disease stage or severity, age range) and exclusion criteria (often previous treatments, comorbidities, lab values that fall outside set ranges). The trial pages on this site translate the clinical eligibility criteria into plain English alongside the original text. Whether you fit any specific trial is a medical decision your doctor needs to confirm.
Is participating in a Phase 3 Respiratory Syncytial Virus (rsv) trial safe?
Phase 3 trials use treatments that have already passed Phase 1 (safety in small groups) and Phase 2 (initial efficacy and side-effect monitoring), so the safety profile is better understood than in earlier-phase studies. That said, side effects can still emerge in larger populations, and the trial protocol may require additional procedures (lab draws, imaging, biopsies) beyond standard care. The informed consent document for any specific trial details the known risks. Discuss those risks with your physician before deciding whether to participate.
Where does this trial data come from?
All trial data is sourced from the ClinicalTrials.gov API v2, the federal registry maintained by the National Library of Medicine at NIH. Under FDAAA 801, most U.S. drug and device trials must register on ClinicalTrials.gov, making it the most comprehensive source of trial information. Sponsors are required to update trial status within 30 days of a change, but delays occur — always confirm the current status with the trial site before traveling for screening.
How This Page Is Built
The trial list is filtered to ClinicalTrials.gov registrations whose phase field includes Phase 3 and whose condition list includes Respiratory Syncytial Virus (rsv). Trial counts and the sponsor leaderboard are computed from the same record set. Plain-English eligibility translations on each linked trial page preserve the original clinical text alongside the accessible version. Read the full methodology for the data pipeline and known limitations.
Phase 3 Trials for Other Conditions
Source: ClinicalTrials.gov API v2, maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData, Phase 3 Respiratory Syncytial Virus (rsv) list, June 2026. Data: ClinicalTrials.gov."
Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.
Last updated 2026-06-26 · 12 Phase 3 trials tracked for Respiratory Syncytial Virus (rsv).