Trial reportInfluenza and other respiratory viruses2020
Clinical phase II and III studies of an AS03-adjuvanted H5N1 influenza vaccine produced in an EB66
Trial report in Influenza and other respiratory viruses, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Clinical phase II and III studies of an AS03-adjuvanted H5N1 influenza vaccine produced in an EB66Influenza and other respiratory viruses · 2020Trial
- Advances in Serum-Free Suspension Culture Technology for Animal Cells and Their Applications.Vaccines · 2025Review
- Avian Influenza Virus A(H5Nx) and Prepandemic Candidate Vaccines: State of the Art.International journal of molecular sciences · 2024Review
- Headache After Vaccination: An Update on Recent Clinical Trials and Real-World Reporting.Current pain and headache reports · 2022Review
- A comprehensive overview of vaccines developed for pandemic viral pathogens over the past two decades including those in clinical trials for the current novel SARS-CoV-2.RSC advances · 2021Review
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe have developed an AS03-adjuvanted H5N1 influenza vaccine produced in an EB66
objectivesIn accordance with Japanese guidelines for development of pandemic prototype vaccines, the phase II study was conducted in a double-blind, randomized, parallel-group comparison study and the phase III study was conducted in an open-label, non-randomized, uncontrolled study.
methodsHealthy adult volunteers aged 20 - 64 years enrolled in the phase II and III studies (N = 248 and N = 369) received KD-295 intramuscularly twice with a 21-day interval. After administration, immune response and adverse events were evaluated. In the phase II study, four different vaccine formulations were compared: MA (3.75 μg hemagglutinin [HA] antigen + AS03 adjuvant system), MB (3.75 μg HA + 1/2AS03), HA (7.5 μg HA + AS03), and HB (7.5 μg HA + 1/2AS03). In the phase III study, the MA formulation was further evaluated.
resultsIn the phase II study, all four vaccine formulations were well-tolerated and no SAE related to vaccination were observed. The MA formulation was slightly more immunogenic and less reactogenic among the vaccine formulations. Therefore, the MA formulation was selected for the phase III study, and it was well-tolerated and no serious adverse drug reactions were observed. The vaccine fulfilled the three immunogenicity criteria described in the Japanese guidelines.
conclusionsThese data indicate that the MA formulation of KD-295 was well-tolerated and highly immunogenic and it can be considered a useful pandemic and pre-pandemic influenza vaccine.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.