[Clinical trial on safety of inactivated split influenza virus vaccine, Anflu in 2007-2008]

Xu Wang1, Yan Liu, Yan-Wei Zhao

  • 1Sinovac Biotech Co., Ltd, Beijing 100085, China.

Zhongguo Yi Miao He Mian Yi
|January 21, 2010
PubMed

Insights

The inactivated split influenza vaccine, Anflu, demonstrated a favorable safety profile in a large-scale population study. Few adverse events were reported, with most being mild and transient, indicating Anflu is a safe vaccine option.

Area of Science:

  • Immunology
  • Vaccinology
  • Public Health

Background:

  • Influenza remains a significant global health concern, necessitating effective vaccination strategies.
  • Inactivated split influenza vaccines are widely used for seasonal influenza prevention.
  • Assessing the safety of new vaccine formulations in diverse populations is crucial.

Purpose of the Study:

  • To evaluate the safety and tolerability of the inactivated split influenza vaccine, Anflu.
  • To assess Anflu's safety profile across a broad age range in a large-scale population.

Main Methods:

  • A nationwide study involving 14 districts was conducted.
  • Inactivated split influenza vaccine, Anflu, was administered to participants across various age groups (infants to elders).
  • Adverse events following immunization (AEFI) were monitored for seven days post-vaccination.

Main Results:

  • A total of 2,794 volunteers aged 6 months to 90 years participated.
  • The overall incidence of adverse events was 6.6%, with the majority being mild reactions.
  • No severe, infrequent, or novel adverse events were reported. Local reactions occurred at a rate of 2.1%, and systemic events at 5.0% (fever 3.8%).

Conclusions:

  • The inactivated split influenza vaccine, Anflu, was found to be safe.
  • Anflu demonstrated a favorable safety profile in a large, diverse population.
  • The vaccine is well-tolerated with a low incidence of mild adverse events.
Abstract