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NCT Number: NCT01906190

Persistence of Immune Response After Vaccination With Influenza Vaccine

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.

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Key information

Conditions

Influenza, Human Immunisation Reaction Infections Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuoketuo Centers for Disease Control & Prevention

Tuoketuo County, Inner Mongolia, 102000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. change from serum antibodies against vaccine-related influenza virus at 6,12,18,24 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention, China

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2013
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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