Influenza, HumanNCT01906190
Persistence of Immune Response After Vaccination With Influenza Vaccine
A study testing seasonal influenza vaccine in people with Influenza, Human and Immunisation Reaction, run by Centers for Disease Control and Prevention, China at 1 site in China.
Trial summary
This clinical study will be performed in subjects aged 12-60 years old enrolled in NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the immune response of influenza vaccine up to 24 months after vaccination. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Immunisation Reaction
- What is being tested?
- seasonal influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Jul 2013
- Phase
- Interventional
- 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
Who may be able to join
- aged 12-60 years old
- male or non-pregnant female
- volunteers received 2010 seasonal influenza vaccine
- clinically healthy as determined by: medical history inquiring and physical examination
- provide written informed consents before joining the trial
Who cannot join
- without history of 2010 seasonal influenza vaccine administration,
- allergic to any ingredient of vaccine,
- autoimmune disease or immunodeficiency,
- severe adverse reaction after vaccination, such as allergies, hives, breathing difficulties, angioedema or abdominal pain,
- severe acute and chronic diseases
- axillary temperature over 37.0℃ at the time of vaccination.
Trial locations and contacts
1 site in 1 country.
China1 site
Tuoketuo Centers for Disease Control & Prevention
Tuoketuo County, Inner Mongolia, 102000
About this study
Official title: Persistence Study of Immune Response After Vaccination With Influenza Vaccine in Healthy Population
This clinical study will be performed in subjects aged 12-60 years old enrolled in NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the immune response of influenza vaccine up to 24 months after vaccination.
Read the detailed description
Subjects were previously vaccinated at 12 to 60 years of age with 2010 seasonal influenza vaccine.The persistence phase starts 24 months after the primary vaccination and blood samples will be taken at 6, 12, 18 and 24 months after primary vaccination. Subjects whose antibody titer less than 1:40 at 6 months after primary vaccination will receive a booster dose of influenza vaccine.
- Conditions
- Influenza, Human, Immunisation Reaction
- Being tested
- seasonal influenza vaccine
- Keywords
- influenza vaccine, immune response, persistence
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seasonal influenza vaccineBiological
subjects whose antibodies less than 1:40 6 months later after primary vaccination will receive a booster dose of seasonal influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| vaccinated group | Experimental | Vaccinated group means that subjects whose antibodies less than 1:40 6 months later after primary vaccination will receive a booster dose of seasonal influenza vaccine. Receives: Biological: seasonal influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from serum antibodies against vaccine-related influenza virus at 6,12,18,24 months
Persistence of antibodies in all subjects with respect to components of the investigational vaccine - month 6，12，18，24
Measured: 6，12，18，24 months after the primary 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 startAug 2011
- Primary completionMar 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 Influenza, HumanStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT01906190
- Sponsor's protocol ID
- BJCDCWJ201104
- Status last verified
- Jul 2013
- First submitted
- 9 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
- Persistence Study of Immune Response After Vaccination With Influenza Vaccine in Healthy Population
- ClinicalTrials.gov ID
- NCT01906190
- Acronym / sponsor ID
- BJCDCWJ201104
- Conditions
- Influenza, Human, Immunisation Reaction
- Keywords
- influenza vaccine, immune response, persistence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Study start
- Aug 2011
- Primary completion
- Mar 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.
This clinical study will be performed in subjects aged 12-60 years old enrolled in NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the immune response of influenza vaccine up to 24 months after vaccination.
Detailed description
Subjects were previously vaccinated at 12 to 60 years of age with 2010 seasonal influenza vaccine.The persistence phase starts 24 months after the primary vaccination and blood samples will be taken at 6, 12, 18 and 24 months after primary vaccination. Subjects whose antibody titer less than 1:40 at 6 months after primary vaccination will receive a booster dose of influenza vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccinated group | Experimental | Biological: seasonal influenza vaccineVaccinated group means that subjects whose antibodies less than 1:40 6 months later after primary vaccination will receive a booster dose of seasonal influenza vaccine. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- aged 12-60 years old
- male or non-pregnant female
- volunteers received 2010 seasonal influenza vaccine
- clinically healthy as determined by: medical history inquiring and physical examination
- provide written informed consents before joining the trial
Key exclusion criteria (6 listed)
- without history of 2010 seasonal influenza vaccine administration,
- allergic to any ingredient of vaccine,
- autoimmune disease or immunodeficiency,
- severe adverse reaction after vaccination, such as allergies, hives, breathing difficulties, angioedema or abdominal pain,
- severe acute and chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| seasonal influenza vaccinesubjects whose antibodies less than 1:40 6 months later after primary vaccination will receive a booster dose of seasonal influenza vaccine | Biological | vaccinated group |
Primary outcome
change from serum antibodies against vaccine-related influenza virus at 6,12,18,24 months
Time frame: 6，12，18，24 months after the primary vaccination
Persistence of antibodies in all subjects with respect to components of the investigational vaccine - month 6，12，18，24
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, Bachelor principal investigator
Beijing Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing seasonal influenza vaccine in people with Influenza, Human and Immunisation Reaction, run by Centers for Disease Control and Prevention, China at 1 site in 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 6 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.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
change from serum antibodies against vaccine-related influenza virus at 6,12,18,24 months (time frame: 6，12，18，24 months after the primary 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.