Persistence of Immune Response After Vaccination With Influenza Vaccine

Persistence Study of Immune Response After Vaccination With Influenza Vaccine in Healthy Population

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01906190

Enrollment

207

Registered

2013-07-24

Start date

2011-08-31

Completion date

2013-07-31

Last updated

2013-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunisation Reaction, Influenza, Human

Keywords

influenza vaccine, immune response, persistence

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.

Interventions

BIOLOGICALseasonal influenza vaccine

subjects whose antibodies less than 1:40 6 months later after primary vaccination will receive a booster dose of seasonal influenza vaccine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026