Persistence of Immune Response After Vaccination With Influenza Vaccine

N/ACompletedNCT01906190

Centers for Disease Control and Prevention, China207 enrolled

Overview

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

207

Conditions

Influenza, Human Immunisation Reaction

Interventions

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

Eligibility

Sex: ALLMin age: 12 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Tuoketuo Centers for Disease Control & Prevention

Tuoketuo County, Inner Mongolia, China

Outcomes

Primary Outcomes

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

Time frame: 6，12，18，24 months after the primary vaccination

Data from ClinicalTrials.gov

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