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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified February 2026 by AstraZeneca
Sponsor
AstraZeneca
Information Provided by (Responsible Party)
AstraZeneca
Clinicaltrials.gov Identifier
NCT07128615
Other Study ID Numbers:
D8500C00001
First Submitted
August 4, 2025
First Posted
August 18, 2025
Last Update Posted
March 22, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Influenza A
Biological: AZD4117Biological: AZD4117Biological: AZD4117Biological: AZD4117Biological: AZD5315Biological: AZD5315Biological: AZD5315Biological: AZD5315Other: PlaceboOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment405 participants
Design AllocationRandomized
Interventional ModelSequential Assignment
MaskingQuadruple
Primary PurposePrevention
Official TitleA 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)
Study Start DateSeptember 3, 2025
Actual Primary Completion DateJanuary 27, 2026
Actual Study Completion Date7mos 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm 1: Dosage Level 1 (DL1) of AZD4117 18 to 64 years of age
Participants will receive DL1 AZD4117.
Biological: AZD4117
Intramuscular (IM) injection
Arm 2: Dosage Level 2 (DL2) of AZD4117 18 to 64 years of age
Participants will receive DL2 AZD4117.
Biological: AZD4117
Intramuscular (IM) injection
Arm 3: DL1 of AZD4117 >= 65 years of age
Participants will receive DL1 AZD4117.
Biological: AZD4117
Intramuscular (IM) injection
Arm 4: DL2 of AZD4117 >= 65 years of age
Participants will receive DL2 AZD4117.
Biological: AZD4117
Intramuscular (IM) injection
Arm 5: DL1 of AZD5315 18 to 64 years of age
Participants will receive DL1 AZD5315.
Biological: AZD5315
IM injection
Arm 6: DL2 of AZD5315 18 to 64 years of age
Participants will receive DL2 AZD5315.
Biological: AZD5315
IM injection
Arm 7: DL1 of AZD5315 >= 65 years of age
Participants will receive DL1 AZD5315.
Biological: AZD5315
IM injection
Arm 8: DL2 of AZD5315 >= 65 years of age
Participants will receive DL2 AZD5315.
Biological: AZD5315
IM injection
Arm 9: placebo 18 to 64 years of age
Participants will receive placebo.
Other: Placebo
IM injection
Arm 10: placebo >= 65 years of age
Participants will receive placebo.
Other: Placebo
IM injection

Outcome Measures

Primary Outcome Measures
  1. Percentage of participants with immediate unsolicited adverse events (AE)
  2. Percentage of participants with injection site and systemic solicited adverse reactions (AR)
  3. Percentage of participants with unsolicited AE
  4. Percentage of participants with serious adverse events (SAE)
  5. Percentage of participants with medically attended adverse events (MAAE)
  6. Percentage of participants with adverse events of special interest (AESI)
  7. Proportion of participants achieving ≥ 1:40 HAI titer post-IMP administration
    A binary endpoint, defined as ≥ 1:40 HAI titer post-IMP administration.
  8. Proportion of participants achieving seroconversion post-IMP administration
    Seroconversion status, defined as either a pre-IMP administration HAI titer \< 1:10 and a post-IMP administration HAI titer ≥ 1:40, or a pre-IMP administration titer ≥ 1:10 and 4-fold increase in post-IMP administration titer.
Secondary Outcome Measures
  1. Geometric mean titer (GMT) of HAI antibody
  2. Geometric mean fold-rise (GMFR) of HAI antibody titers from baseline
    The fold rise is calculated as the ratio of the post-dose titer to the pre-dose titer.
  3. Proportion of participants achieving a ≥1:40 HAI titer post-IMP administration
    A binary endpoint, defined as ≥ 1:40 HAI titer post-IMP administration.
  4. Proportion of participants achieving seroconversion post-IMP administration
    Seroconversion status, defined as either a pre-IMP administration HAI titer \< 1:10 and a post-IMP administration HAI titer ≥ 1:40, or a pre-IMP administration titer ≥ 1:10 and 4-fold increase in post-IMP administration titer.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
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 Key
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)
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

Contacts and Locations

Sponsors and CollaboratorsAstraZeneca
Locations
Research Site | Long Beach California, United States, 90815Research Site | Rolling Hills Estates California, United States, 90274Research Site | Hialeah Florida, United States, 33012Research Site | Stockbridge Georgia, United States, 30281Research Site | Chicago Illinois, United States, 60640Research Site | Lenexa Kansas, United States, 66219Research Site | Kansas City Missouri, United States, 64114Research Site | Omaha Nebraska, United States, 68134Research Site | Las Vegas Nevada, United States, 89119Research Site | Cincinnati Ohio, United States, 45212Research Site | Edmond Oklahoma, United States, 73013Research Site | North Charleston South Carolina, United States, 29405Research Site | Austin Texas, United States, 78745Research Site | West Jordan Utah, United States, 84088