Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23

Summary

The main objective of this study was to evaluate the immunogenicity and safety of the booster dose of COVID-19 inactivated vaccine and co-immunization with quadrivalent influenza vaccine and 23-valent pneumonia polysaccharide vaccine in people aged 18 years and older. A randomized controlled, open trial design was adopted. The study was conducted with informed consent of the subjects for immunogenicity and safety in the population aged 18 years and older. A total of 3000 healthy subjects were selected, (1)600 healthy subjects were selected for the immunogenicity and safety study of co-immunization, 300 in the adult group (18-59 years old) and 300 in the elderly group (60 years old and above); (2) 2400 healthy subjects were selected for the observational study of the safety of co-immunization, 1200 in the adult group (18-59 years old) and 1200 in the elderly group (60 years old and above ) 1200 people.

Timeline

Start

2021-10-08

Primary completion

2022-12-31

Completion

2023-12-31

Publications

• Bai S, Zhou S, Zhang J, Chen W, Lv M, Wang J, Zhang A, Wu J, Zhao W. Immunogenicity and safety of different combinations involving a third booster dose of SARS-CoV-2 inactivated vaccine, inactivated quadrivalent influenza vaccine, and 23-valent pneumococcal polysaccharide vaccine in adults aged >/=60 years: a phase 4, randomized, open-label study. Front Immunol. 2024 Aug 20;15:1437267. doi: 10.3389/fimmu.2024.1437267. eCollection 2024.
• Zhou S, Lv M, Bai S, Chen W, Zhao W, Wang J, Zhang A, Li J, Xie H, Gao Y, Li D, Wu J. Baseline Pneumococcal IgG Levels and Response to 23-Valent Pneumococcal Polysaccharide Vaccine among Adults from Beijing, China. Vaccines (Basel). 2023 Nov 29;11(12):1780. doi: 10.3390/vaccines11121780.

Drugs

Indications

No indication recorded.