Back to resultsSafety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60
Primary Purpose
Quadrivalent Influenza Virus Vaccine
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
one dose test vaccine
one dose commercially available trivalent influenza 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, immunogenicity
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
one dose test vaccine
one dose commercially available trivalent influenza vaccine
One dose quadrivalent influenza virus vaccine
Arm Description
One dose of quadrivalent influenza virus vaccine will be randomly given in aged 3-60 years old.
One dose of trivalent influenza virus vaccine will be randomly given in aged 3-60 years old.
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.
Outcomes
Primary Outcome Measures
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
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.
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
NCT02806804
First Posted
June 15, 2016
Last Updated
June 16, 2016
Sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT02806804
Brief Title
Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
undefined (undefined)
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 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.
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, immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
one dose test vaccine
Arm Type
Experimental
Arm Description
One dose of quadrivalent influenza virus vaccine will be randomly given in aged 3-60 years old.
Arm Title
one dose commercially available trivalent influenza vaccine
Arm Type
Experimental
Arm Description
One dose of trivalent influenza virus vaccine will be randomly given in aged 3-60 years old.
Arm Title
One dose quadrivalent influenza virus vaccine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
one dose test vaccine
Intervention Type
Biological
Intervention Name(s)
one dose commercially available trivalent influenza vaccine
Intervention Type
Biological
Intervention Name(s)
One dose of Quadrivalent Influenza Virus Vaccine
Primary Outcome Measure Information:
Title
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
Description
The serum antibody titers will be evaluated at 28 days after vaccination.
Time Frame
28 days
Title
Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.
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
28 days
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 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.
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60
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