NCT07332689

Safety Study of Quadrivalent Subunit Influenza Vaccine in People Aged 3 Years and Older

A Safety Study of Quadrivalent Subunit Influenza Vaccine in a Large-Scale Population Aged 3 Years and Older

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42,881 (actual)
• Sponsor: Ab&B Bio-tech Co., Ltd.JS · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the safety of the quadrivalent subunit influenza vaccine following its post-marketing widespread use in individuals aged 3 years and older, aiming to assess the occurrence of very rare adverse reactions (with an incidence rate of \<0.01%).

Detailed description

This is a large-scale, multicenter, open-label, single-arm, non-controlled real-world safety observational study following influenza vaccination. It is designed to assess the occurrence of very rare adverse reactions (incidence \<0.01%) following vaccination with a quadrivalent influenza subunit vaccine and to demonstrate its superior safety profile. A total of 42,881 participants aged 3 years and above were enrolled. Each received a single 0.5 ml dose of the quadrivalent influenza subunit vaccine. Safety monitoring included immediate observation for 30 minutes post-vaccination and systematic surveillance over the subsequent 28 days. Data on adverse events (AEs) and serious adverse events (SAEs) were collected during two time intervals: from 30 minutes to 7 days (inclusive) and from 8 to 28 days (inclusive) after vaccination. Any newly identified adverse reactions during the study period were also recorded.

Conditions

• Influenza Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	quadrivalent subunit influenza vaccine	one dose of quadrivalent subunit influenza vaccine

Timeline

• Start date: 2023-10-30
• Primary completion: 2025-04-28
• Completion: 2025-04-28
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

8 sites across 1 country: China