1913. Immunogenicity and Safety of a Cell Culture-derived Quadrivalent Inactivated Influenza Vaccine: A Phase III Randomized Controlled Trial in Adults and Elderly Subjects
Session: Poster Abstract Session: Vaccines: Influenza
Saturday, October 10, 2015
Room: Poster Hall
Background: The influenza B virus has two lineages; Yamagata and Victoria. The two lineages are antigenically distinct and it is difficult to expect cross-protection between the lineages. Actually, the mismatch between circulating influenza B viruses and vaccine strains has been occurred frequently. The cell-culture system for the production of influenza vaccine can contribute to improve vaccine stain selection and expand vaccine supplies. We investigated the immunogenicity and safety of cell culture-derived quadrivalent inactivated influenza vaccine (NBP607-QIV) in adults and elderly subjects.

Methods: In a randomized controlled phase III trial undertaken in 10 university hospitals in Republic of Korea, adults (aged 19-59 years) and elderly subjects (aged ≥60 years) were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine-Yamagata (NBP607-Y) and cell culture-based trivalent inactivated influenza vaccine-Victoria (NBP607-V). Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition assay. Safety was assessed for 6 months post-vaccination: solicited adverse events (AEs) for 7 days, unsolicited AEs for 21 days and serious adverse events (SAEs) for 6 months.

Results: 1,503 participants were randomly assigned to NBP607-QIV (n=752), NBP607-Y (n=373) and NBP607-V (n=378). The seroconversion rates of NBP607-QIV were 52.4%, 51.2%, 43.7% and 55.8% against A/H1N1, A/H3N2, B/Yamagata and B/Victoria, respectively. Non-inferiority against shared strains and superiority against alternate-lineage B strains were demonstrated for NBP607-QIV vs. NBP607-Y and NBP607-V. AEs were reported from 48.5% of NBP607-QIV group. Majority of AEs was solicited and mild in intensity. In adults (aged 19-59 years), solicited local AEs were slightly more frequent in NBP607-QIV group than NBP607-Y or NBP607-V group (40.9%, 33.4% and 32.5%, respectively). One SAE was observed among NBP607-QIV group, which was considered to be unrelated to the study vaccine.

Conclusion: NBP607-QIV is a safe, well-tolerated and immunogenic influenza vaccine for Korean adults and elderly subjects.

Won Suk Choi, MD, PhD1, Seong-Heon Wie, MD, PhD2, Jin Soo Lee, MD, PhD3, Jacob Lee, MD4, Shin-Woo Kim, MD, PhD5, Hye Won Jeong, MD, PhD6, Sook-in Jung, MD, PhD7, Yeon-Sook Kim, MD, PhD8, Heungjeong Woo, MD, PhD4, Kyung Ho Kim, PhD9, Hun Kim, PhD9 and Woo Joo Kim, MD, PhD1, (1)Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea, (2)Division of Infectious Diseases, Department of Internal Medicine, St. Vincent Hospital Catholic University, Suwon, South Korea, (3)Division of Infectious Diseases, Department of Internal Medicine, Inha University College of Medicine, Incheon, South Korea, (4)Division of Infectious Diseases, Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea, (5)Division of Infectious Diseases, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, South Korea, (6)Division of Infectious Diseases, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, South Korea, (7)Division of Infectious Diseases, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, South Korea, (8)Division of Infectious Diseases, Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, (9)Life Science Research Institute, SK Chemicals, Seongnam-si, South Korea

Disclosures:

W. S. Choi, SK Chemical: Research Contractor , Research support

S. H. Wie, SK Chemical: Research Contractor , Research support

J. S. Lee, SK Chemical: Research Contractor , Research support

J. Lee, SK Chemicals: Research Contractor , Research support

S. W. Kim, SK Chemicals: Research Contractor , Research support

H. W. Jeong, SK Chemicals: Research Contractor , Research support

S. I. Jung, SK Chemicals: Research Contractor , Research support

Y. S. Kim, SK Chemicals: Research Contractor , Research support

H. Woo, SK Chemicals: Research Contractor , Research support

K. H. Kim, SK Chemicals: Employee , Salary

H. Kim, SK Chemicals: Employee , Salary

W. J. Kim, SK Chemicals: Research Contractor , Research support

See more of: Vaccines: Influenza
See more of: Poster Abstract Session

Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 7th with the exception of research findings presented at the IDWeek press conferences.