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Persistence of Immune Response After Vaccination With Influenza Vaccine

C

Centers for Disease Control and Prevention, China

Status

Completed

Conditions

Influenza, Human
Immunisation Reaction

Treatments

Biological: seasonal influenza vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT01906190
BJCDCWJ201104

Details and patient eligibility

About

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.

Full 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.

Enrollment

207 patients

Sex

All

Ages

12 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

207 participants in 1 patient group

vaccinated group
Experimental group
Description:
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.
Treatment:
Biological: seasonal influenza vaccine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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