InfluenzaNCT02136017
Post-License Safety Evaluation of Influenza Virus Vaccine
An observational study of Influenza and Adverse Drug Event, run by Sichuan Center for Disease Control and Prevention.
Trial summary
To evaluate the safety of the post-licensed influenza virus vaccine made of Changchun Institute of Biological Products Co.,Ltd. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Influenza, Adverse Drug Event
- Type of treatment
- Vaccines
- How many people
- 400,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2013
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: all the people immunized by influenza vaccine of Changchun Institute of Biological Product in Sichuan province in 2013.
Who may be able to join
- ever vaccinated one dose influenza vaccine(manufactured by Changchun institute of biological product) in 2013
- above 3 years old
Who cannot join
- Severe allergic reaction (e.g., anaphylaxis) after previous dose of any IIV or LAIV
- allergic to a vaccine component, including egg protein.
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza, Adverse Drug Event
- Keywords
- AEFI, influenza vaccine
- Medical subject headings
- Influenza, Human, Drug-Related Side Effects and Adverse Reactions
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 |
|---|---|---|
| Changchun biologial's vaccine | Changchun Biological'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.
occurence rate of adverse reaction
the general or local reactions are reported after vaccination .
Measured: 1 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- China National Biotec Group Company Limited
- Responsible party
- Sponsor
- Investigators
- rui ao, master, Principal investigator, Sichuan CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136017
- Sponsor's protocol ID
- cnbg-002
- Status last verified
- May 2014
- First submitted
- 8 May 2014
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Post-License Safety Evaluation of Influenza Split Vaccine
- ClinicalTrials.gov ID
- NCT02136017
- Acronym / sponsor ID
- cnbg-002
- Conditions
- Influenza, Adverse Drug Event
- Keywords
- AEFI, influenza vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400,000 participants (actual)
- Lead sponsor
- Sichuan Center for Disease Control and PreventionOther government
- Collaborators
- China National Biotec Group Company Limited
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 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 evaluate the safety of the post-licensed influenza virus vaccine made of Changchun Institute of Biological Products Co.,Ltd.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Changchun biologial's vaccine | – | –Changchun Biological's vaccine group is the population injected with this vaccine. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all the people immunized by influenza vaccine of Changchun Institute of Biological Product in Sichuan province in 2013.
Key inclusion criteria (2 listed)
- ever vaccinated one dose influenza vaccine(manufactured by Changchun institute of biological product) in 2013
- above 3 years old
Key exclusion criteria (2 listed)
- Severe allergic reaction (e.g., anaphylaxis) after previous dose of any IIV or LAIV
- allergic to a vaccine component, including egg protein.
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
occurence rate of adverse reaction
Time frame: 1 month after vaccination
the general or local reactions are reported after vaccination .
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 12 May 2014.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
rui ao, master principal investigator
Sichuan CDC
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Adverse Drug Event, run by Sichuan Center for Disease Control and Prevention.
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 2 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 12 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?
occurence rate of adverse reaction (time frame: 1 month 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 12 May 2014.