Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Administered Concomitantly with a 23-Valent Pneumococcal Polysaccharide Vaccine in Adults Aged 60 Years and Older.

Zhongkui Zhu, Jianwen Sun, Yan Xie, Xi Lu, Wanqin Tang, Yanwei Zhao, Lu Shen, Huaxian Liu, Yang Yu, Siliang Zhou, Liqun Huo, Peng Jiao, Xiaoli Jiang
Author Information
  1. Zhongkui Zhu: Department of Immunization Program, Taizhou City Center for Disease Control and Prevention, Taizhou 225300, China.
  2. Jianwen Sun: Department of Medical Affairs, Sinovac Biotech Co., Ltd., Beijing 100089, China.
  3. Yan Xie: Department of Immunization Program, Taizhou City Center for Disease Control and Prevention, Taizhou 225300, China.
  4. Xi Lu: Department of Medical Affairs, Sinovac Biotech Co., Ltd., Beijing 100089, China.
  5. Wanqin Tang: Department of Immunization Program, Taizhou City Center for Disease Control and Prevention, Taizhou 225300, China.
  6. Yanwei Zhao: Department of Medical Affairs, Sinovac Biotech Co., Ltd., Beijing 100089, China.
  7. Lu Shen: Department of Immunization Program, Taizhou City Center for Disease Control and Prevention, Taizhou 225300, China.
  8. Huaxian Liu: Department of Immunization Program, Taizhou City Center for Disease Control and Prevention, Taizhou 225300, China.
  9. Yang Yu: Department of Immunization Program, Taizhou City Center for Disease Control and Prevention, Taizhou 225300, China.
  10. Siliang Zhou: Department of Medical Affairs, Sinovac Biotech Co., Ltd., Beijing 100089, China.
  11. Liqun Huo: Department of Medical Affairs, Sinovac Biotech Co., Ltd., Beijing 100089, China.
  12. Peng Jiao: Department of Medical Affairs, Sinovac Biotech Co., Ltd., Beijing 100089, China.
  13. Xiaoli Jiang: Department of Immunization Program, Taizhou City Center for Disease Control and Prevention, Taizhou 225300, China.

Abstract

The inactivated quadrivalent influenza vaccine (IIV4) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) have been administered for years and could be administered concomitantly if necessary. However, the immunogenicity and safety of the concomitant administration of these two vaccines have not been well documented, especially in the Chinese population. In this study, 480 participants aged 60 years and older were randomly assigned to the concomitant administration group (C group) or the separate administration group (S group) to receive IIV4 and PPSV23 either concomitantly or separately. Blood samples were collected before and 28 days after each vaccination. The antibodies against four influenza virus strains and twenty-three pneumococcus serotypes were tested. The results showed that the geometric mean titer (GMT) ratios (C group to S group) for the four influenza strains ranged from 0.72 to 0.95, with the lower limits of the 95% confidence intervals (CIs) ranging from 0.51 to 0.75, and the geometric mean concentration (GMC) ratios for the 23 pneumococcal serotypes ranged from 0.80 to 1.00, with the lower limits of 95% CIs ranging from 0.67 to 0.86. All values met the predefined criteria for non-inferiority. The incidence of adverse events was 0.63% in the C group and 1.56% in the S group. No serious adverse events were observed. In conclusion, the immunogenicity of the concomitant administration of IIV4 and PPSV23 was non-inferior to that of the separate administration, and the safety profile was favorable in adults aged 60 years and older in China.

Keywords

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Grants

  1. No grant number/Sinovac Biotech Co., Ltd.

Word Cloud

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