Back to resultsSafety Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged 3 Years and Older
Primary Purpose
Quadrivalent Influenza Virus Vaccine
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
One dose of Quadrivalent Influenza Virus Vaccine
One dose of Quadrivalent Influenza Virus Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Quadrivalent Influenza Virus Vaccine focused on measuring vaccine, safety
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 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.
Sites / Locations
- DongBa clinical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
One dose Vaccine in aged 18-60 years old
One dose Vaccine in aged 3-17 years old
Arm Description
One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 18-60 years old.
One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 3-17 years old.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02708173
First Posted
March 10, 2016
Last Updated
August 12, 2016
Sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT02708173
Brief Title
Safety Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged 3 Years and Older
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadrivalent Influenza Virus Vaccine
Keywords
vaccine, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One dose Vaccine in aged 18-60 years old
Arm Type
Experimental
Arm Description
One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 18-60 years old.
Arm Title
One dose Vaccine in aged 3-17 years old
Arm Type
Experimental
Arm Description
One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 3-17 years old.
Intervention Type
Biological
Intervention Name(s)
One dose of Quadrivalent Influenza Virus Vaccine
Intervention Type
Biological
Intervention Name(s)
One dose of Quadrivalent Influenza Virus Vaccine
Primary Outcome Measure Information:
Title
The rate of adverse reactions of Quadrivalent Influenza Virus Vaccine
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Facility Information:
Facility Name
DongBa clinical center
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
12. IPD Sharing Statement
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Safety Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged 3 Years and Older
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