Persistence of Immune Response After Vaccination With Influenza Vaccine

NCT01906190 | Completed DMC

• 1 other identifier: BJCDCWJ201104
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human; Immunisation Reaction

Keywords

influenza vaccine; immune response; persistence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

vaccinated group

EXPERIMENTAL

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.

Biological: seasonal influenza vaccine

Interventions

seasonal influenza vaccine BIOLOGICAL

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

vaccinated group

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention, China: lead

Study Sites (1)

Tuoketuo Centers for Disease Control & Prevention

Tuoketuo County, Inner Mongolia, 102000, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• jiang wu, Bachelor

  Beijing Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Immunization & Prevention, Beijing Centers for Disease Control and Prevention

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 24, 2013
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 24, 2013

Record last verified: 2013-07

Locations

CN (1)