Influenza Clinical Trial
Official title:
A Post-marketing Safety Study of SIBP's Inactivated, Split-virion Influenza Vaccine Administered in Chinese Subjects Aged 3 Years and Older
To monitor the safety of Shanghai Institute of Biological Products Company's influenza
vaccine in subjects aged 3 years and older through Adverse Events Following Immunization
Surveillance System of China.
The hypothesis is that there is no significant difference in the occurrence of adverse
events among influenza vaccines manufactured by SIBP and other companies.
Inactivated split-virion vaccines from Shanghai Institute of Biological Products Company
have been used for more than 10 years in Beijing population. Some 160 thousands doses have
been sold to subjects aged 3 years and older in this area. We review and summarize
spontaneously reported adverse events from safety surveillance.
Adverse events were collected through the Adverse Events Following Immunization (AEFI)
Surveillance System. Beijing CDC and local prefectural CDC must organize an expert panel to
investigate adverse events and assess causality, using criteria based on Chinese Standard
Procedures for Vaccination. The panels consist of physicians, epidemiologists, pharmacists,
and other relevant experts. In general, expert panels investigate deaths, life-threatening
illnesses, and permanent disabilities, and immunization-program managers or vaccination
providers investigate common, minor adverse events. Adverse events are classified into one
of five categories: vaccine reactions (common and minor to rare and more serious), program
errors, coincidental illnesses, psychogenic reactions, and unclassifiable events.
At the time of vaccination, vaccinees were instructed to report any adverse event to
physicians or vaccination providers. The following adverse events were required to be
reported: adverse events that were fatal or that resulted in disability and clusters of
events (i.e., notably high numbers of similar adverse events related to a certain vaccine) ;
anaphylaxis or other allergic reactions occurring within 24 hours after vaccination; fever
(axillary temperature, >37.5°C), angioedema, or a local injection-site reaction (diameter,
>2.5 cm) occurring within 5 days after vaccination; purpura, an Arthus reaction, febrile
convulsion, seizure, or polyneuritis occurring within 15 days after vaccination; and the
Guillain-Barré syndrome occurring within 3 months after vaccination. Other reactions that
were common and minor (e.g., mild pain and fatigue) were not required to be reported.
;
Observational Model: Ecologic or Community
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