InfluenzaNCT01906593
A Post-marketing Safety Study of Beijing Tiantan Biological's Influenza Virus Vaccine in Elderly
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 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Vaccination Adverse Event
- Type of treatment
- Vaccines
- How many people
- 536,812 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jul 2013
- How long will I take part?
- 1 Year
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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 Study to Monitor the Safety of Beijing Tiantan Biological's Influenza Virus Vaccine Administered in Chinese Subjects Aged 60 Years or Older
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.
Read the detailed description
In 2011 and 2012, Beijing Municipal Health Bureau launched the free influenza vaccination campaign among children aged 6-18 years old and the elderly aged 60 years old and above. Inactivated split-virion vaccines from Beijing Tiantan Biological Products Company were used for the elderly in the campaign.
All vaccine recipients provided written informed consent, containing information about the vaccine, possible adverse effects, and medical care.
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, 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. 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, 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 |
|---|---|---|
| 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. |
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. 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.
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 posted24 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 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
- Ecologic or community
- Enrolment
- 536,812 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
- Collaborators
- Beijing Tiantan Biological Products Co., Ltd.
- 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
- NCT01906593
- Sponsor's protocol ID
- BJCDCWJ201301
- Status last verified
- Mar 2013
- First submitted
- 20 Jul 2013
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Study to Monitor the Safety of Beijing Tiantan Biological's Influenza Virus Vaccine Administered in Chinese Subjects Aged 60 Years or Older
- ClinicalTrials.gov ID
- NCT01906593
- Acronym / sponsor ID
- BJCDCWJ201301
- Conditions
- Influenza, Vaccination Adverse Event
- Keywords
- safety, influenza vaccine, post-marketing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 536,812 participants (actual)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Collaborators
- Beijing Tiantan Biological Products Co., Ltd.
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Jul 2013 (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 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.
Detailed description
In 2011 and 2012, Beijing Municipal Health Bureau launched the free influenza vaccination campaign among children aged 6-18 years old and the elderly aged 60 years old and above. Inactivated split-virion vaccines from Beijing Tiantan Biological Products Company were used for the elderly in the campaign.
All vaccine recipients provided written informed consent, containing information about the vaccine, possible adverse effects, and medical care.
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, 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. 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
- Ecologic or community
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
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. 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.
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 24 Jul 2013.
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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 24 Jul 2013. 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 24 Jul 2013.