InfluenzaNCT02133456
A Post-marketing Safety Study of Inactivated, Split-virion Influenza Vaccine in Subjects Aged 3 Years and Older
An observational study of Influenza and Vaccination Adverse Event, run by Centers for Disease Control and Prevention, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Vaccination Adverse Event
- Type of treatment
- Vaccines
- How many people
- 166,240 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Beijing subjects aged 3 years or older, at the time of routine visit to a participating clinic or hospital for influenza vaccination.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza, Vaccination Adverse Event
- Keywords
- safety, influenza vaccine, post-marketing
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SIBP's vaccine | SIBP's vaccine group is the population injected with this vaccine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Enrolment
- 166,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
- Collaborators
- Shanghai Institute Of Biological Products
- Responsible party
- Principal investigator, Wu Jiang, Centers for Disease Control and Prevention, China
- Investigators
- Jiang Wu, Master, Principal investigator, Beijing Centers for Disease Prevention and Control, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133456
- Sponsor's protocol ID
- BJCDCWJ201401
- Status last verified
- May 2014
- First submitted
- 7 May 2014
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Safety Study of SIBP's Inactivated, Split-virion Influenza Vaccine Administered in Chinese Subjects Aged 3 Years and Older
- ClinicalTrials.gov ID
- NCT02133456
- Acronym / sponsor ID
- BJCDCWJ201401
- Conditions
- Influenza, Vaccination Adverse Event
- Keywords
- safety, influenza vaccine, post-marketing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166,240 participants (actual)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Collaborators
- Shanghai Institute Of Biological Products
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIBP's vaccine | – | –SIBP's vaccine group is the population injected with this vaccine. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Beijing subjects aged 3 years or older, at the time of routine visit to a participating clinic or hospital for influenza vaccination.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Wu, Master principal investigator
Beijing Centers for Disease Prevention and Control, China
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Vaccination Adverse Event, run by Centers for Disease Control and Prevention, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of reported adverse events (time frame: 3 months after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.