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

NCT ID: NCT02806804

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 2400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31

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.

Conditions

Quadrivalent Influenza Virus Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

one dose test vaccine

One dose of quadrivalent influenza virus vaccine will be randomly given in aged 3-60 years old.

Group Type: EXPERIMENTAL

one dose test vaccine

Intervention Type: BIOLOGICAL

one dose commercially available trivalent influenza vaccine

One dose of trivalent influenza virus vaccine will be randomly given in aged 3-60 years old.

Group Type: EXPERIMENTAL

one dose commercially available trivalent influenza vaccine

Intervention Type: BIOLOGICAL

One dose quadrivalent influenza virus vaccine

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.

Group Type: EXPERIMENTAL

One dose of Quadrivalent Influenza Virus Vaccine

Intervention Type: BIOLOGICAL

Interventions

one dose test vaccine

Intervention Type: BIOLOGICAL

one dose commercially available trivalent influenza vaccine

Intervention Type: BIOLOGICAL

One dose of Quadrivalent Influenza Virus Vaccine

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Chaoyang District Centre for Disease Control and Prevention

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

cycdc2016-1

Identifier Type: -

Identifier Source: org_study_id