Clinical trial NCT02806804: Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Quadrivalent Influenza Virus Vaccine
Keywords: vaccine
safety
immunogenicity
Lead sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 2400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
timeFrame: 28 days
measure: Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: