A Post-marketing Safety Study of Beijing Tiantan Biological's Influenza Virus Vaccine in Elderly

NCT01906593 | Completed DMC

• 1 other identifier: BJCDCWJ201301
• Study Type: observational
• Target: 536,812
• Locations: 0 countries
• Sites: N/A

Brief Summary

To monitor the safety of Beijing Tiantan Biological's influenza vaccine in elderly 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 independent 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. The cumulative 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 from the beginning of the first week to the end of each week.

  3 months after vaccination

Study Arms (2)

Tiantan biologial's vaccine

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

other group

Other vaccine group is the population injected with other manufacturers' vaccine except Tiantan Biological CO, Ltd.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Beijing subjects aged 60 years or older, at the time of routine visit to a participating clinic or hospital for annual influenza vaccination.

You may qualify if:

• Males and females aged 60 years and above on the day of immunization, who are eligible for seasonal influenza vaccination.
• In the judgement of the study doctor are determined to be in reasonable health considering their age and able to comply with all study procedure.

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
• Beijing Tiantan Biological Products Co., Ltd.: 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
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing Centers for Disease Control and Prevention

Study Record Dates

• First Submitted: July 20, 2013
• First Posted: July 24, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 24, 2013

Record last verified: 2013-03