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

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

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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