Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Quadrivalent Influenza Virus Vaccine
- Sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- Enrollment
- 2400
- Primary Endpoint
- Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
- Last Updated
- 9 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
Time Frame: 28 days
The serum antibody titers will be evaluated at 28 days after vaccination.
Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.
Time Frame: 28 days
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.