Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III,open label,single-arm study |
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| Affiliation: | 1. Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan;2. Departments of Pediatrics, National Taiwan University Children''s Hospital and National Taiwan University College of Medicine, Taipei, Taiwan;1. Department of Research and Evaluation, Kaiser Permanente Southern California, 100 S. Los Robles, California Suite 201, Pasadena, CA 91101, USA;2. Pediatrics and Pediatric Infectious Diseases, Southern California Permanente Medical Group, 25965 S Normandie Ave, Harbor City, CA, USA;3. GSK, Clinical Research and Development Center, Via Fiorentina, 1, 53100 Siena SI, Italy;1. State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China;2. Zhejiang Chinese Medical University, Hangzhou 310053, China;1. China National Biotec Group Company Limited, Beijing, China;2. Tianjin Centers for Disease Control and Prevention, Tianjin, China;3. Beijing Center for Diseases and Prevention Control, Beijing, China;4. Beijing Chaoyang District Center for Diseases and Prevention Control, Beijing, China;5. Tianjin Jinghai District Center for Disease Control and Prevention, Tianjin, China;1. UMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal;2. Center for Vaccine Innovation and Access, PATH, Seattle, USA;3. Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA;4. Kanesa, LLC, Cambridge, USA;5. Senegal Ministry of Health and Social Welfare, Dakar, Senegal;6. Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, USA;7. Division of Global Health Protection, CDC Kenya, Center for Global Health, Centers for Disease Control and Prevention, Nairobi, Kenya;8. Division of Global Health Protection, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, USA;1. Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 29003, United States;2. Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia |
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| Abstract: | BackgroundQuadrivalent influenza vaccines are particularly valuable during seasons in which a mismatch occurs between the predicted influenza B lineage for the trivalent influenza vaccine and the circulating strain. This study evaluated the immunogenicity and safety of a quadrivalent inactivated influenza vaccine AdimFlu-S manufactured in Taiwan for the 2016–2017 influenza season in healthy children.MethodsA total of 174 healthy children aged 3 to 17 years old were separated into 3 groups (Group A: 3–8 years old, vaccine naïve; Group B: 3–8 years old, vaccine non-naïve; Group C: 9–17 years old, any vaccine status). Sera was collected pre and post vaccination for each participant. A hemagglutination inhibition (HAI) assay was utilized to calculate geometric mean titer (GMT), seroprotection rate, and seroconversion rate.ResultsAll enrolled participants completed the study. For the four vaccine strains four weeks after the last vaccination, geometric mean titer ratios (GMTRs) were between 2.9 and 20.9, seroconversion rates were between 42.9% and 90.9%, and seroprotection rates were all above 96.4%. This achieved all immunogenicity endpoints and fulfilled the criteria of the European Medical Agency’s Committee for Medicinal Products for Human Use (CHMP). No serious adverse events (AEs) were reported during the follow-up period of 6 months.ConclusionThis quadrivalent influenza vaccine is demonstrated to be well tolerated and displays robust immunogenicity for each influenza strain. This could potentially improve protection against the antigenically distinct B/Yamagata and B/Victoria lineages. |
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| Keywords: | Immunogenicity Safety Influenza Quadrivalent Split viron vaccine Children |
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