ClinicalTrials.Veeva

Menu

Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60

B

Beijing Chaoyang District Centre for Disease Control and Prevention

Status and phase

Unknown
Phase 3

Conditions

Quadrivalent Influenza Virus Vaccine

Treatments

Biological: one dose test vaccine
Biological: One dose of Quadrivalent Influenza Virus Vaccine
Biological: one dose commercially available trivalent influenza vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT02806804
cycdc2016-1

Details and patient eligibility

About

This study evaluates the safety and immunogenicity of the quadrivalent influenza virus vaccine in healthy people aged years 3-60.Subjects will be randomly divided into 3 groups,receiving the test vaccine, commercially available trivalent influenza vaccine and trivalent influenza vaccine containing new influenza B component respectively. Each group has 800 subjects,2400 in total.

Enrollment

2,400 estimated patients

Sex

All

Ages

3 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy subjects more than 3 years old, and the subjects can be informed consent, and sign the informed consent.
  • the subjects and his guardians can obey the demands of the scheme .
  • Axillary temperature less than 37℃

Exclusion criteria

  • The people who has flu or influenza-like symptoms(fever <axillary temperature ≥38 ℃>, cough or sore throat) within 3 months
  • The people who has vaccinated influenza vaccine in 3years.
  • The people who has a vaccine allergies, or who allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc.
  • The people who has serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
  • the subject who has symptoms of acute infection within a week.
  • Autoimmune diseases or Immune function defect, people has immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
  • People has congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)
  • People has asthma Unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years.
  • Diagnosed abnormal coagulation(Lack of clotting factors,Clotting disorders,Platelet abnormality) or significant bruising or coagulopathy
  • people has history or family history of convulsions, seizures, encephalopathy and psychiatric.
  • alienia, functional asplenia, and alienia or splenectomy in any situation.
  • Serious neurological disorders such as Green Barry syndrome.
  • people who has received blood products or immunoglobulin products in the past one months.
  • people who has received other study drug in the past one month.
  • people who received live attenuated vaccine, subunit vaccine or inactivated vaccine.
  • people who has received allergy treatment in in the past 14 days.
  • People who is on anti-TB treatment.
  • People whose axillary temperature is more than 37℃ before the vaccination.
  • People who is pregnant.
  • Any factors unsuitable for clinical trail according to the researchers.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

2,400 participants in 3 patient groups

one dose test vaccine
Experimental group
Description:
One dose of quadrivalent influenza virus vaccine will be randomly given in aged 3-60 years old.
Treatment:
Biological: one dose test vaccine
one dose commercially available trivalent influenza vaccine
Experimental group
Description:
One dose of trivalent influenza virus vaccine will be randomly given in aged 3-60 years old.
Treatment:
Biological: one dose commercially available trivalent influenza vaccine
One dose quadrivalent influenza virus vaccine
Experimental group
Description:
One dose of quadrivalent influenza virus vaccine (trivalent influenza virus vaccine added to a new influenza B component) will be randomly given in aged 3-60 years old.
Treatment:
Biological: One dose of Quadrivalent Influenza Virus Vaccine

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems