Influenza Vaccine AllergyNCT01310374
Immune Response Study of Influenza Vaccine
An observational study of Influenza Vaccine Allergy and Cell Mediated Reaction, run by Centers for Disease Control and Prevention, China.
Trial summary
An observational clinical study will be performed in subjects aged 12-60 years old to describe the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine, and to discuss the role of different antibodies against influenza virus infection, and to look for possible factors related to… Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccine Allergy, Cell Mediated Reaction
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Dec 2012
- 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 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: community sample
Who may be able to join
- aged 12-60 years old
- male or non-pregnant female
- volunteers
- clinically healthy as determined by: medical history inquiring and physical examination
- provide written informed consents before joining the trial
Who cannot join
- infected with Influenza A virus subtype H1N1(2009),
- vaccinated with seasonal influenza vaccine,
- allergic to any ingredient of vaccine,
- autoimmune disease or immunodeficiency,
- active malignancy,
- bleeding disorder,
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- seizure disorder,
- Guillain-Barre Syndrome,
- treatment with cytotoxic or immunosuppressive drugs within the past 6 months,
- receipt of blood products within the past 3 months,
- administration of any other investigational research agents or live attenuated vaccine within 30 days,
- administration of subunit or inactivated vaccines within 14 days,
- axillary temperature over 37.0℃ at the time of vaccination.
About this study
Official title: Humoral and Cellular Immune Response Study of Influenza Vaccine
An observational clinical study will be performed in subjects aged 12-60 years old to describe the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine, and to discuss the role of different antibodies against influenza virus infection, and to look for possible factors related to side effects with the vaccine.
Read the detailed description
A randomized clinical trial will be conducted to describe immune response of seasonal influenza virus vaccine in a single center in China. 200 subjects aged 18-60 years will be enrolled under the premise of informed consent and receive one dose of vaccine. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at 0,7,14,28 days for antibody detection and split vaccine neutralizing antibody detection, determination of cellular immune function in the same time.
The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.
- Conditions
- Influenza Vaccine Allergy, Cell Mediated Reaction
- Keywords
- influenza vaccine, immune response, dynamic changes
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Vaccine AllergyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wu Jiang, Centers for Disease Control and Prevention, China
- Investigators
- jiang wu, Bachelor, Principal investigator, Beijing Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310374
- Sponsor's protocol ID
- BJCDCWJ201101
- Status last verified
- Jul 2013
- First submitted
- 7 Mar 2011
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humoral and Cellular Immune Response Study of Influenza Vaccine
- ClinicalTrials.gov ID
- NCT01310374
- Acronym / sponsor ID
- BJCDCWJ201101
- Conditions
- Influenza Vaccine Allergy, Cell Mediated Reaction
- Keywords
- influenza vaccine, immune response, dynamic changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Mar 2011 (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.
An observational clinical study will be performed in subjects aged 12-60 years old to describe the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine, and to discuss the role of different antibodies against influenza virus infection, and to look for possible factors related to side effects with the vaccine.
Detailed description
A randomized clinical trial will be conducted to describe immune response of seasonal influenza virus vaccine in a single center in China. 200 subjects aged 18-60 years will be enrolled under the premise of informed consent and receive one dose of vaccine. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at 0,7,14,28 days for antibody detection and split vaccine neutralizing antibody detection, determination of cellular immune function in the same time.
The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- community sample
Key inclusion criteria (5 listed)
- aged 12-60 years old
- male or non-pregnant female
- volunteers
- clinically healthy as determined by: medical history inquiring and physical examination
- provide written informed consents before joining the trial
Key exclusion criteria (13 listed)
- infected with Influenza A virus subtype H1N1(2009),
- vaccinated with seasonal influenza vaccine,
- allergic to any ingredient of vaccine,
- autoimmune disease or immunodeficiency,
- active malignancy,
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 dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine
Time frame: one year
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 10 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, Bachelor principal investigator
Beijing Centers for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Vaccine Allergy and Cell Mediated Reaction, 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 5 inclusion and 13 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 10 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 dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine (time frame: one year). 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 10 Jul 2013.