- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02133456
A Post-marketing Safety Study of Inactivated, Split-virion Influenza Vaccine in Subjects Aged 3 Years and Older
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
Cohorts and Interventions
Group / Cohort |
---|
SIBP's vaccine
SIBP's vaccine group is the population injected with this vaccine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the rate of reported adverse events
Time Frame: 3 months after vaccination
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jiang Wu, Master, Beijing Centers for Disease Prevention and Control, China
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BJCDCWJ201401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Influenza
-
Novartis VaccinesCompletedInfluenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza VirusBelgium
-
Gamaleya Research Institute of Epidemiology and...CompletedInfluenza A | Influenza A Virus Infection | Influenza Epidemic | Influenza H5N1Russian Federation
-
Vanderbilt University Medical CenterHuman Vaccines ProjectCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Influenza Type B | Influenza A H3N2 | Influenza A H1N1United States
-
NPO PetrovaxCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Acute Respiratory Infection | Influenza Type B | Flu | Influenza A H3N2 | Influenza A H1N1 | Flu, Human | Influenza EpidemicRussian Federation
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Influenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH)CompletedInfluenza AUnited States