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A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)

A Phase I/II, Double-blinded, Randomized, Placebo-Controlled, Dose Selection Study in Adults to Assess the Safety and Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)

NCT07128615•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and immunogenicity of two investigational vaccines, AZD4117 and AZD5315 to protect against certain strains of avian Influenza A (H5N1 and H7N9 subtypes).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Adults, ≥ 18 years of age at the time of signing the informed consent
•Participants who are medically stable such that, according to the judgement of the Investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrollment
•Written informed consent and any locally required authorization (eg, HIPAA in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations

Exclusion Criteria

•History of hypersensitivity to any component of the IMP
•History of hypersensitivity to penicillin and its derivatives
•History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis associated with a vaccine
•Known or suspected congenital or acquired immunodeficiency
•Abnormal findings on screening laboratory tests
•Previous history of myocarditis, pericarditis, Guillain-Barré syndrome or any other demyelinating condition
•Known or suspected autoimmune conditions as determined by history and/or physical examination
•Receipt of any other type of seasonal influenza vaccination from 14 days before the first dose until 28 days after the administration of the last dose of IMP
•Receipt of an mRNA vaccine within 28 days before administration of IMP
•Receipt or expected receipt of any other type of licensed or investigational vaccine within 28 days prior to Visit 1 (D1) or Visit 5 (D58)
+7 more criteria

Locations (14)

Research Site

Long Beach, California, United States

Research Site

Rolling Hills Estates, California, United States

Research Site

Hialeah, Florida, United States

Research Site

Stockbridge, Georgia, United States

Research Site

Chicago, Illinois, United States

Research Site

Lenexa, Kansas, United States

Research Site

Kansas City, Missouri, United States

Research Site

Omaha, Nebraska, United States

Research Site

Las Vegas, Nevada, United States

Research Site

Cincinnati, Ohio, United States

Key Dates

Start Date

September 4, 2025

Primary Completion Date

January 20, 2026

Completion Date

December 29, 2026

Last Updated

December 17, 2025

Enrollment

405

ACTUAL participants

Conditions

Influenza A

Interventions

AZD4117

BIOLOGICAL

AZD5315

BIOLOGICAL

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)

Inclusion Criteria

Exclusion Criteria

Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans®

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