Persistence of Immune Response After Vaccination With Influenza Vaccine

Influenza, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906190
• Other study ID #: BJCDCWJ201104
• 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

• Immunisation Reaction
• Influenza, Human

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