The Immunogenicity and Safety of 2012-2013 Trivalent Seasonal Influenza Vaccine
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
2012-2013 trivalent seasonal influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring 2012-2013 trivalent seasonal influenza vaccine, immunogenicity,, safety
Eligibility Criteria
For adults and old people:
Inclusion Criteria:
- Healthy adults aged 18-60 years old, and healthy old people aged >60 years
- Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
- Not participate in any other clinical trials during the study
- Not receive any immunosuppressive agents during and one month prior to the study
- Be able to understand and sign the informed consent.
Exclusion Criteria:
- Woman: Who breast-feeding or planning to become pregnant during the study
- Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
- Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
- Guillain-Barre Syndrome
- Women subjects with positive urinary pregnancy test
- Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- Axillary temperature >37.0 centigrade at the time of dosing
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
For infants:
Inclusion Criteria:
- Healthy male or female aged between 6 and 35 months
- Full-term birth, birth weight 2,500 grams or more
- provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent
Exclusion Criteria:
- Administration of 2012-2013 seasonal vaccine
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Symptoms of acute infection within a week
- Autoimmune disease or immunodeficiency
- Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
- Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with Intramuscular injections or blood draws
- History or family history of convulsions, epilepsy, brain disease and psychiatric
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Guillain-Barre Syndrome
- History of any blood products within 3 months
- Administration of any other investigational research agents within 30 days
- Administration of any live attenuated vaccine within 30 days
- Administration of subunit or inactivated vaccines within 14 days
- Be receiving anti-Tuberculosis prophylaxis or therapy currently
- Axillary temperature > 37.0 centigrade at the time of dosing
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Sites / Locations
- Henan Center for Diseases Control and Prevention
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
trivalent seasonal influenza vaccine
Arm Description
2012-2013 trivalent seasonal influenza vaccine in 60 infants with two-dose regimen, 21 days interval trivalent seasonal influenza vaccine in 60 adults and 60 old people with single-dose regimen
Outcomes
Primary Outcome Measures
Hemagglutination inhibition (HI) antibody titer of 2012-2013 trivalent seasonal influenza vaccine
to evaluate the immunogenicity of the vaccine in adults and old people.
Secondary Outcome Measures
Frequency of systemic and local adverse reactions after vaccination
to evaluate the safety of the vaccine in healthy infants, adults, and old people
Full Information
NCT ID
NCT01736709
First Posted
November 26, 2012
Last Updated
May 27, 2013
Sponsor
Sinovac Biotech Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01736709
Brief Title
The Immunogenicity and Safety of 2012-2013 Trivalent Seasonal Influenza Vaccine
Official Title
A Single-centered, Open-labeled, Phase 4 Study of 2012-2013 Trivalent Seasonal Influenza Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of 2012-2013 trivalent seasonal influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy older people aged > 60 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
2012-2013 trivalent seasonal influenza vaccine, immunogenicity,, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trivalent seasonal influenza vaccine
Arm Type
Experimental
Arm Description
2012-2013 trivalent seasonal influenza vaccine in 60 infants with two-dose regimen, 21 days interval trivalent seasonal influenza vaccine in 60 adults and 60 old people with single-dose regimen
Intervention Type
Biological
Intervention Name(s)
2012-2013 trivalent seasonal influenza vaccine
Intervention Description
trivalent seasonal influenza vaccine with 0.25 ml ⁄ vial, for infants trivalent seasonal influenza vaccine with 0.5 ml ⁄ vial, for adults and old people
Primary Outcome Measure Information:
Title
Hemagglutination inhibition (HI) antibody titer of 2012-2013 trivalent seasonal influenza vaccine
Description
to evaluate the immunogenicity of the vaccine in adults and old people.
Time Frame
21 days after vaccination
Secondary Outcome Measure Information:
Title
Frequency of systemic and local adverse reactions after vaccination
Description
to evaluate the safety of the vaccine in healthy infants, adults, and old people
Time Frame
0-21 days after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For adults and old people:
Inclusion Criteria:
Healthy adults aged 18-60 years old, and healthy old people aged >60 years
Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
Not participate in any other clinical trials during the study
Not receive any immunosuppressive agents during and one month prior to the study
Be able to understand and sign the informed consent.
Exclusion Criteria:
Woman: Who breast-feeding or planning to become pregnant during the study
Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
Autoimmune disease or immunodeficiency
Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
Guillain-Barre Syndrome
Women subjects with positive urinary pregnancy test
Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
Axillary temperature >37.0 centigrade at the time of dosing
Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
For infants:
Inclusion Criteria:
Healthy male or female aged between 6 and 35 months
Full-term birth, birth weight 2,500 grams or more
provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent
Exclusion Criteria:
Administration of 2012-2013 seasonal vaccine
Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
Symptoms of acute infection within a week
Autoimmune disease or immunodeficiency
Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with Intramuscular injections or blood draws
History or family history of convulsions, epilepsy, brain disease and psychiatric
Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
Guillain-Barre Syndrome
History of any blood products within 3 months
Administration of any other investigational research agents within 30 days
Administration of any live attenuated vaccine within 30 days
Administration of subunit or inactivated vaccines within 14 days
Be receiving anti-Tuberculosis prophylaxis or therapy currently
Axillary temperature > 37.0 centigrade at the time of dosing
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan-Shen Guo, BS
Organizational Affiliation
Henan Center for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Center for Diseases Control and Prevention
City
Zhengzhou
State/Province
Henan
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Immunogenicity and Safety of 2012-2013 Trivalent Seasonal Influenza Vaccine
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