Persistence of Immune Response After Vaccination With Influenza Vaccine

Not Applicable

Completed

• Conditions: Influenza, Human; Immunisation Reaction
• Interventions: Biological: seasonal influenza vaccine

• Registration Number: NCT01906190
• Lead Sponsor: Centers for Disease Control and Prevention, China

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-03
• Status Verified: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-19
• Last Update Submitted: 2013-07-19
• Study First Posted: 2013-07-24
• Last Update Posted: 2013-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vaccinated group	seasonal influenza vaccine	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.

Primary Outcome Measures

Name	Time	Method
change from serum antibodies against vaccine-related influenza virus at 6,12,18,24 months	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

Trial Locations

Locations (1)

Tuoketuo Centers for Disease Control & Prevention; 🇨🇳 Tuoketuo County, Inner Mongolia, China