Post-License Safety Evaluation of Influenza Virus Vaccine

NCT ID: NCT02136017

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-12-31

Brief Summary

To evaluate the safety of the post-licensed influenza virus vaccine made of Changchun Institute of Biological Products Co.,Ltd.

Detailed Description

In order to evaluate the safety of the post-licensed influenza vaccine (the vaccine is manufactured by Changchun Institute of Biological Products Co.,Ltd in China), retrospectively collect the AEFI cases reported from national AEFI surveillance system in Sichuan province of China in 2013, compare the incidence and proportion of local and general reactions, with other influenza vaccine.

Adverse events were collected through the National Immunization Information System's National Adverse Events Following Immunization (AEFI) Surveillance System, which was established in 2005 on the basis of World Health Organization (WHO) guidelines. According to the Guideline for the Identification of Adverse Reaction after Immunization issued by the Chinese Ministry of Health in 2008, Sichuan 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.

At the time of vaccination, vaccinees were instructed to report any adverse event to physicians or vaccination providers. 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) were required to be reported within 2 hours after their occurrence. The following adverse events were required to be reported within 2 days after their occurrence: 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.

Conditions

Influenza; Adverse Drug Event

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Changchun biologial's vaccine

Changchun Biological's vaccine group is the population injected with this vaccine.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• ever vaccinated one dose influenza vaccine(manufactured by Changchun institute of biological product) in 2013
• above 3 years old

Exclusion Criteria

• Severe allergic reaction (e.g., anaphylaxis) after previous dose of any IIV or LAIV
• allergic to a vaccine component, including egg protein.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Biotec Group Company Limited

INDUSTRY

Sponsor Role: collaborator

Sichuan Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

rui ao, master

Role: PRINCIPAL_INVESTIGATOR

Sichuan CDC

Other Identifiers

cnbg-002

Identifier Type: -

Identifier Source: org_study_id