A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)
NCT ID: NCT07128615
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
405 participants
INTERVENTIONAL
2025-09-04
2026-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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Arm 1: Dosage Level 1 (DL1) of AZD4117 18 to 64 years of age
Participants will receive DL1 AZD4117.
AZD4117
Intramuscular (IM) injection
Arm 2: Dosage Level 2 (DL2) of AZD4117 18 to 64 years of age
Participants will receive DL2 AZD4117.
AZD4117
Intramuscular (IM) injection
Arm 3: DL1 of AZD4117 >= 65 years of age
Participants will receive DL1 AZD4117.
AZD4117
Intramuscular (IM) injection
Arm 4: DL2 of AZD4117 >= 65 years of age
Participants will receive DL2 AZD4117.
AZD4117
Intramuscular (IM) injection
Arm 5: DL1 of AZD5315 18 to 64 years of age
Participants will receive DL1 AZD5315.
AZD5315
IM injection
Arm 6: DL2 of AZD5315 18 to 64 years of age
Participants will receive DL2 AZD5315.
AZD5315
IM injection
Arm 7: DL1 of AZD5315 >= 65 years of age
Participants will receive DL1 AZD5315.
AZD5315
IM injection
Arm 8: DL2 of AZD5315 >= 65 years of age
Participants will receive DL2 AZD5315.
AZD5315
IM injection
Arm 9: placebo 18 to 64 years of age
Participants will receive placebo.
Placebo
IM injection
Arm 10: placebo >= 65 years of age
Participants will receive placebo.
Placebo
IM injection
Interventions
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AZD4117
Intramuscular (IM) injection
AZD5315
IM injection
Placebo
IM injection
Eligibility Criteria
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Inclusion Criteria
* 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 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)
* Receipt of immunoglobulin or blood products within 6 months prior to administration of study intervention or expected receipt during the study
* Receipt of immune-modifying drugs or immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within 6 months prior to enrollment (or expected receipt during study), or long-term systemic corticosteroid therapy (prednisolone or equivalent at a dose of ≥ 20 mg daily for more than 2 consecutive weeks) within 6 months prior to enrollment or expected receipt during study. Topical/inhaled steroids or short-term oral steroids are permitted
* Participation in another trial, or receiving interventional Study IMP, in the preceding 90 days or expected receipt of another study intervention (or participation in another trial) during the period of study follow-up
* Acute (time-limited) or febrile (temperature ≥ 38.0 °C \[100.4 °F\]) illness/infection within 3 days of intended IMP administration
* Individuals who have had a previous confirmed or suspected illness from influenza caused by an H5N1 or H7N9 virus
* Individuals who had household contact with and/or intimate exposure to an individual with laboratory confirmed H5N1 infection, exposure to infected household poultry/ wild birds/cattle or contaminated environments with sick and dead poultry or wild birds or cattle, within 60 days prior to enrollment
* Female participants who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to IMP administration and until at least 6 months after IMP administration
18 Years
ALL
Yes
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Joint Program Executive Office (JPEO) Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB)
UNKNOWN
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Research Site
Edmond, Oklahoma, United States
Research Site
North Charleston, South Carolina, United States
Research Site
Austin, Texas, United States
Research Site
West Jordan, Utah, United States
Countries
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Other Identifiers
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D8500C00001
Identifier Type: -
Identifier Source: org_study_id