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

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.

Study Overview

• Status: Unknown
• Conditions: Quadrivalent Influenza Virus Vaccine
• Intervention / Treatment: Biological: one dose test vaccine; Biological: one dose commercially available trivalent influenza vaccine; Biological: One dose of Quadrivalent Influenza Virus Vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 2400
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one dose test vaccine; One dose of quadrivalent influenza virus vaccine will be randomly given in aged 3-60 years old.	Biological: one dose test vaccine
Experimental: one dose commercially available trivalent influenza vaccine; One dose of trivalent influenza virus vaccine will be randomly given in aged 3-60 years old.	Biological: one dose commercially available trivalent influenza vaccine
Experimental: 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.	Biological: One dose of Quadrivalent Influenza Virus Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.	The serum antibody titers will be evaluated at 28 days after vaccination.	28 days
Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.	Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy.	28 days

Collaborators and Investigators

• Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: safety; vaccine; immunogenicity
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: cycdc2016-1