Back to resultsPersistence of Immune Response After Vaccination With Influenza Vaccine
Primary Purpose
Influenza, Human, Immunisation Reaction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
seasonal influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza, Human focused on measuring influenza vaccine, immune response, persistence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Tuoketuo Centers for Disease Control & Prevention
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vaccinated group
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01906190
First Posted
July 9, 2013
Last Updated
July 19, 2013
Sponsor
Centers for Disease Control and Prevention, China
1. Study Identification
Unique Protocol Identification Number
NCT01906190
Brief Title
Persistence of Immune Response After Vaccination With Influenza Vaccine
Official Title
Persistence Study of Immune Response After Vaccination With Influenza Vaccine in Healthy Population
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centers for Disease Control and Prevention, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Immunisation Reaction
Keywords
influenza vaccine, immune response, persistence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vaccinated group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
seasonal influenza vaccine
Intervention Description
subjects whose antibodies less than 1:40 6 months later after primary vaccination will receive a booster dose of seasonal influenza vaccine
Primary Outcome Measure Information:
Title
change from serum antibodies against vaccine-related influenza virus at 6,12,18,24 months
Description
Persistence of antibodies in all subjects with respect to components of the investigational vaccine - month 6，12，18，24
Time Frame
6，12，18，24 months after the primary vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jiang wu, Bachelor
Organizational Affiliation
Beijing Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuoketuo Centers for Disease Control & Prevention
City
Tuoketuo County
State/Province
Inner Mongolia
ZIP/Postal Code
102000
Country
China
12. IPD Sharing Statement
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Persistence of Immune Response After Vaccination With Influenza Vaccine
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