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Updated May 2026 · ClinicalTrials.gov

Phase 3 Influenza Trials

13 Phase 3 trials for Influenza, the final stage before a treatment can be submitted for FDA approval.

13 Phase 3 clinical trials for Influenza 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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

What Phase 3 Means for Influenza

Phase 3 trials are the largest and most expensive stage of clinical research before potential FDA approval. For Influenza, 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.

13 Phase 3 trials for Influenza 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.

Jiangxi Qingfeng Pharmaceutical Co. Ltd. (2), Joincare Pharmaceutical Group Industry Co., Ltd (1), AstraZeneca (1) lead the Phase 3 Influenza 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 Influenza Trials on ClinicalTrials.gov

RECRUITINGPhase 3NCT07357051

Phase III Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of JKN2301 Dry Suspension in Pediatric...

The goal of this phase III study is to learn if JKN2301 Dry Suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.

Sponsor: Joincare Pharmaceutical Group Industry Co., LtdEnrolling: 1771 location
RECRUITINGPhase 3NCT05624450

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of...

Sponsor: AstraZenecaEnrolling: 287020 locations
RECRUITINGPhase 3NCT07496450

A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults

The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of...

Sponsor: ModernaTX, Inc.Enrolling: 400020 locations
RECRUITINGPhase 3NCT04381936

Randomised Evaluation of COVID-19 Therapy

RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia. The treatments being investigated are: COVID-19: Lopinavir-Ritonavir,...

Sponsor: University of OxfordEnrolling: 7000016 locations
RECRUITINGPhase 3NCT06531707

Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine

Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the drug combination of...

Sponsor: Laboratorios Silanes S.A. de C.V.Enrolling: 1771 location
RECRUITINGPhase 3NCT06573008

Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications

This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 and older With Influenza...

Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.Enrolling: 3281 location
RECRUITINGPhase 3NCT06094010

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission...

This study consists of two parts: Part A Surveillance and Part B Transmission. The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino...

Sponsor: Hoffmann-La RocheEnrolling: 110020 locations
RECRUITINGPhase 3NCT07171099

Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children

The goal of this clinical trial is to evaluate the efficacy and safety of liquid dosage form of Rengalin in the treatment of cough in acute viral upper respiratory tract...

Sponsor: Materia Medica HoldingEnrolling: 26420 locations
RECRUITINGPhase 3NCT06574503

Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza

Index patients who are infected with influenza virus (Q-PCR positive) can be treated with anti-influenza drugs if their influenza symptoms onset was within 48 hours of screening....

Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.Enrolling: 7481 location
RECRUITINGPhase 3NCT02735707

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of...

Sponsor: UMC UtrechtEnrolling: 2000020 locations
RECRUITINGPhase 3NCT06528444

Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza

Clinical trial with an active ingredient of a pharmaceutical specialty marketed in Spain vs. placebo. Randomized, double-blind, multicenter phase III clinical trial that...

Sponsor: Instituto de Investigación Sanitaria y Biomédica de AlicanteEnrolling: 422 locations
RECRUITINGPhase 3NCT07240558

Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)

Influenza is an important pathogen in transplant recipients. The current widespread outbreak of highly pathogenic H5N1 avian influenza (HPAI) in livestock, and the occurrence of...

Sponsor: University Health Network, TorontoEnrolling: 1201 location
RECRUITINGPhase 3NCT07211152

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women

This is a randomized, double-blind, positive controlled phase Ⅲ clinical trial to assess the immunogenicity and safety of Sinovac QIV in pregnant women. A total of 150 healthy...

Sponsor: Sinovac Biotech Co., LtdEnrolling: 1502 locations

What Participation Looks Like

Phase 3 trials for Influenza 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 Influenza 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 Influenza trial?

A Phase 3 trial is the final stage of clinical testing before a treatment can be submitted to the FDA for approval. For Influenza, 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 Influenza trials are recruiting?

13 Phase 3 trials for Influenza 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 Influenza 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 Influenza 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 Influenza. 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.

Source: ClinicalTrials.gov API v2, maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData, Phase 3 Influenza list, May 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 2026-05-08 · 13 Phase 3 trials tracked for Influenza.

The this entity category groups every U.S. clinical trials and research registries entity sharing this attribute. The list above is the data; the paragraphs below explain what the grouping means against the broader the NIH ClinicalTrials.gov registry distribution and how to read the relative rankings within the category.

For readers using this category as a starting point, the per-entity detail pages linked from the table above carry the underlying the NIH ClinicalTrials.gov registry data in full. The category-level view is the filter; the per-entity pages are the actual answer.