Phase IV Clinical Trial of an Influenza Split Vaccine Anflu
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
seasonal split influenza vaccine
seasonal split influenza vaccine
seasonal split influenza vaccine
seasonal split influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
Inclusion Criteria:
- Healthy adults aged 18-60 years old
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
1: Lot 1
2: Lot 2
3: Lot 3
4: control vaccine
Arm Description
Outcomes
Primary Outcome Measures
Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B
Secondary Outcome Measures
local and systematic adverse reactions after vaccination
Full Information
NCT ID
NCT00556062
First Posted
November 8, 2007
Last Updated
November 8, 2007
Sponsor
Sinovac Biotech Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00556062
Brief Title
Phase IV Clinical Trial of an Influenza Split Vaccine Anflu
Official Title
The Clinical Trial for Three Consecutive Lots of Influenza Split Vaccine Anflu by Randomized, Double-Blind and Controlled Design
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sinovac Biotech Co., Ltd
4. Oversight
5. Study Description
Brief Summary
To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
566 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Lot 1
Arm Type
Experimental
Arm Title
2: Lot 2
Arm Type
Experimental
Arm Title
3: Lot 3
Arm Type
Experimental
Arm Title
4: control vaccine
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
seasonal split influenza vaccine
Intervention Description
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
Intervention Type
Biological
Intervention Name(s)
seasonal split influenza vaccine
Intervention Description
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
Intervention Type
Biological
Intervention Name(s)
seasonal split influenza vaccine
Intervention Description
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
Intervention Type
Biological
Intervention Name(s)
seasonal split influenza vaccine
Intervention Description
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
Primary Outcome Measure Information:
Title
Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B
Time Frame
0, 21 days
Secondary Outcome Measure Information:
Title
local and systematic adverse reactions after vaccination
Time Frame
within 3 days after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults aged 18-60 years old
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhilun Zhang
Organizational Affiliation
Tianjin centers for Disease Control and Prevention
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Phase IV Clinical Trial of an Influenza Split Vaccine Anflu
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