Safety Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged 3 Years and Older

This study evaluates the safety of Quadrivalent Influenza Virus Vaccine in Healthy People Aged years 3 to 60.40 Subjects will be equally divided into 2 groups,including 3-17 years old and 18-60 years old.Adult group first receive one dose of Quadrivalent Influenza Virus Vaccine.Then minors group also receive one dose of Quadrivalent Influenza Virus Vaccine after 7 days.

Study Overview

• Status: Completed
• Conditions: Quadrivalent Influenza Virus Vaccine
• Intervention / Treatment: Biological: One dose of Quadrivalent Influenza Virus Vaccine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • DongBa clinical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• 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 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: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One dose Vaccine in aged 18-60 years old; One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 18-60 years old.	Biological: One dose of Quadrivalent Influenza Virus Vaccine
Experimental: One dose Vaccine in aged 3-17 years old; One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 3-17 years old.	Biological: One dose of Quadrivalent Influenza Virus Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of adverse reactions of Quadrivalent Influenza Virus Vaccine	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	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 15, 2016

Study Record Updates

• Last Update Posted (Estimate): August 15, 2016
• Last Update Submitted That Met QC Criteria: August 12, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: safety; vaccine
• 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: cycdc2015-5