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)
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
California
Research Site
RECRUITING
Long Beach
Research Site
RECRUITING
Rolling Hills Estates
Florida
Research Site
RECRUITING
Hialeah
Georgia
Research Site
NOT_YET_RECRUITING
Stockbridge
Illinois
Research Site
RECRUITING
Chicago
Kansas
Research Site
RECRUITING
Lenexa
Missouri
Research Site
RECRUITING
Kansas City
Nebraska
Research Site
NOT_YET_RECRUITING
Omaha
Nevada
Research Site
RECRUITING
Las Vegas
Ohio
Research Site
RECRUITING
Cincinnati
Oklahoma
Research Site
NOT_YET_RECRUITING
Edmond
South Carolina
Research Site
NOT_YET_RECRUITING
North Charleston
Texas
Research Site
NOT_YET_RECRUITING
Austin
Utah
Research Site
RECRUITING
West Jordan
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2025-09-04
Estimated Completion Date:2027-01-07
Participants
Target number of participants:400
Treatments
Experimental: Arm 1: Dosage Level 1 (DL1) of AZD4117 18 to 64 years of age
Participants will receive DL1 AZD4117.
Experimental: Arm 2: Dosage Level 2 (DL2) of AZD4117 18 to 64 years of age
Participants will receive DL2 AZD4117.
Experimental: Arm 3: DL1 of AZD4117 >= 65 years of age
Participants will receive DL1 AZD4117.
Experimental: Arm 4: DL2 of AZD4117 >= 65 years of age
Participants will receive DL2 AZD4117.
Experimental: Arm 5: DL1 of AZD5315 18 to 64 years of age
Participants will receive DL1 AZD5315.
Experimental: Arm 6: DL2 of AZD5315 18 to 64 years of age
Participants will receive DL2 AZD5315.
Experimental: Arm 7: DL1 of AZD5315 >= 65 years of age
Participants will receive DL1 AZD5315.
Experimental: Arm 8: DL2 of AZD5315 >= 65 years of age
Participants will receive DL2 AZD5315.
Placebo_comparator: Arm 9: placebo 18 to 64 years of age
Participants will receive placebo.
Placebo_comparator: Arm 10: placebo >= 65 years of age
Collaborators: Biomedical Advanced Research and Development Authority, Joint Program Executive Office (JPEO) Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB)