Persistence of Immune Response After Vaccination With Influenza Vaccine

July 19, 2013 updated by: Wu Jiang, Centers for Disease Control and Prevention, China

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Inner Mongolia
      • Tuoketuo County, Inner Mongolia, China, 102000
        • Tuoketuo Centers for Disease Control & Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vaccinated group
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.
Biological: seasonal influenza vaccine
subjects whose antibodies less than 1:40 6 months later after primary vaccination will receive a booster dose of seasonal influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6，12，18，24 months after the primary vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention, China

Investigators

  • Principal Investigator: jiang wu, Bachelor, Beijing Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 19, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCDCWJ201104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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