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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01906190
Other study ID # BJCDCWJ201104
Secondary ID
Status Completed
Phase N/A
First received July 9, 2013
Last updated July 19, 2013
Start date August 2011
Est. completion date July 2013

Study information

Verified date July 2013
Source Centers for Disease Control and Prevention, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date July 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 60 Years
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Tuoketuo Centers for Disease Control & Prevention Tuoketuo County Inner Mongolia

Sponsors (1)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6,12,18,24 months after the primary vaccination No
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