Post-License Safety Evaluation of Influenza Virus Vaccine

Phase 4 Study of Post-License Safety Evaluation of Influenza Split Vaccine

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

Study Overview

• Status: Completed
• Conditions: Influenza; Adverse Drug Event

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.

• Study Type: Observational
• Enrollment (Actual): 400000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all the people immunized by influenza vaccine of Changchun Institute of Biological Product in Sichuan province in 2013.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Changchun biologial's vaccine; Changchun Biological's vaccine group is the population injected with this vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurence rate of adverse reaction	the general or local reactions are reported after vaccination .	1 month after vaccination

Collaborators and Investigators

• Sponsor: Sichuan Center for Disease Control and Prevention
• Collaborators: China National Biotec Group Company Limited
• Investigators: Principal Investigator: rui ao, master, Sichuan CDC

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 8, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Estimate): May 12, 2014
• Last Update Submitted That Met QC Criteria: May 8, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: influenza vaccine; AEFI
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: cnbg-002