A Post-marketing Safety Study of Inactivated, Split-virion Influenza Vaccine in Subjects Aged 3 Years and Older

NCT02133456 | Completed DMC

• 1 other identifier: BJCDCWJ201401
• Study Type: observational
• Target: 166,240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Influenza; Vaccination Adverse Event

Keywords

safety; influenza vaccine; post-marketing

Outcome Measures

Primary Outcomes (1)

• the rate of reported adverse events

  The rate of reported adverse events was calculated by dividing the number of vaccinees who reported having an event by the number of vaccine doses administered.

  3 months after vaccination

Study Arms (1)

SIBP's vaccine

SIBP's vaccine group is the population injected with this vaccine.

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Beijing subjects aged 3 years or older, at the time of routine visit to a participating clinic or hospital for influenza vaccination.

You may qualify if:

• Males and females aged 3 years and above on the day of immunization, who are eligible for seasonal influenza vaccination.
• Recipients of SIBP's inactivated, split-virion influenza vaccine.

You may not qualify if:

• History of any serious reaction to flu vaccine, or any materials in the vaccine, and to eggs (including ovalbumin) and chicken protein.
• Receipt of a live vaccine within 4 weeks prior to Study Day 1.
• Any condition, which in the opinion of the study doctor, might interfere with the evaluation of the study objective.

Sponsors & Collaborators

• Centers for Disease Control and Prevention, China: lead
• Shanghai Institute Of Biological Products: collaborator

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Jiang Wu, Master

  Beijing Centers for Disease Prevention and Control, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Immunization and Prevention,Beijing Centers for Disease Control and Prevention

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 8, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 8, 2014

Record last verified: 2014-05