A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA) (NCT07128615) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)
United States405 participantsStarted 2025-09-04
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key 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 m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with immediate unsolicited adverse events (AE)
Timeframe: Within 30 minutes after dosing
2
Percentage of participants with injection site and systemic solicited adverse reactions (AR)
Timeframe: Through 7 days after dosing
3
Percentage of participants with unsolicited AE
Timeframe: Through 28 days after the last dose
4
Percentage of participants with serious adverse events (SAE)
Timeframe: Through 12 months after the last dose
5
Percentage of participants with medically attended adverse events (MAAE)
Timeframe: Through 12 months after the last dose
6
Percentage of participants with adverse events of special interest (AESI)
Timeframe: Through 12 months after the last dose
7
Proportion of participants achieving ≥ 1:40 HAI titer post-IMP administration