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A Clinical Trial of A Quadrivalent Influenza Vaccine

Primary Purpose

Influenza

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Quadrivalent influenza vaccine
Trivalent influenza vaccine A
Trivalent influenza vaccine B
Sponsored by
Shanghai Institute Of Biological Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Over the age of three years,healthy population
  • Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
  • To comply with the requirements of clinical trial program
  • Temperature≤37.0℃ on day of enrollment

Exclusion Criteria:

  • A history of influenza virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes in last three months
  • Any prior administration of influenza vaccine in last six months
  • Allergy to any component in the vaccine, especially for egg allergy
  • Allergy history of any previous vaccination or drug
  • Acute episodes of chronic illness or acute illness on the day of vaccination
  • Received a live vaccine within fourteen days prior to receiving the vaccine, or received a subunit or inactivated vaccine within seven days
  • Congenital or acquired immune deficiencies, or treatment with immunosuppressive agents, such as long-term treatment with systemic corticosteroids
  • Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
  • Asthma, required urgent treatment in last two years
  • The blood products were received prior to the acceptance of the vaccine
  • Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases
  • History of epilepsy, convulsions, or a family history of psychosis
  • Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy
  • Plan to move or leave the area for an extended period of time before the end of the study
  • Under anti-tb treatment
  • Any prior administration of other research medicine/vaccine in last one month
  • Women are pregnant or in the near future planned pregnancy or pregnancy test positive

Sites / Locations

  • Suining County Center for Disease Control and Prevention
  • Xinyi County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Quadrivalent influenza vaccine

Trivalent influenza vaccine A

Trivalent influenza vaccine B

Arm Description

Quadrivalent influenza vaccine(containing 2 subtypes of B lineage)

Trivalent influenza vaccine (containing B/Victoria lineage)

Trivalent influenza vaccine (containing B/Yamagata lineage)

Outcomes

Primary Outcome Measures

Number of participants that presented seroconversion post injection
Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Geometric mean of Hemagglutination-inhibition titre post first study injection
Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.

Secondary Outcome Measures

Number of participants that presented seroprotection post injection
Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval

Full Information

First Posted
November 14, 2018
Last Updated
November 16, 2018
Sponsor
Shanghai Institute Of Biological Products
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1. Study Identification

Unique Protocol Identification Number
NCT03744104
Brief Title
A Clinical Trial of A Quadrivalent Influenza Vaccine
Official Title
Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Participants Aged Above 3 Years
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute Of Biological Products

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2688 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quadrivalent influenza vaccine
Arm Type
Experimental
Arm Description
Quadrivalent influenza vaccine(containing 2 subtypes of B lineage)
Arm Title
Trivalent influenza vaccine A
Arm Type
Active Comparator
Arm Description
Trivalent influenza vaccine (containing B/Victoria lineage)
Arm Title
Trivalent influenza vaccine B
Arm Type
Active Comparator
Arm Description
Trivalent influenza vaccine (containing B/Yamagata lineage)
Intervention Type
Biological
Intervention Name(s)
Quadrivalent influenza vaccine
Intervention Description
0.5 mL, intramuscular, one dose
Intervention Type
Biological
Intervention Name(s)
Trivalent influenza vaccine A
Intervention Description
0.5 mL, intramuscular, one dose
Intervention Type
Biological
Intervention Name(s)
Trivalent influenza vaccine B
Intervention Description
0.5 mL, intramuscular, one dose
Primary Outcome Measure Information:
Title
Number of participants that presented seroconversion post injection
Description
Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Time Frame
30 days after inoculation
Title
Geometric mean of Hemagglutination-inhibition titre post first study injection
Description
Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.
Time Frame
30 days after inoculation
Secondary Outcome Measure Information:
Title
Number of participants that presented seroprotection post injection
Description
Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Time Frame
30 days after inoculation
Title
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
Description
For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval
Time Frame
Continuous observation for 30 days after two inoculations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Over the age of three years,healthy population Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required To comply with the requirements of clinical trial program Temperature≤37.0℃ on day of enrollment Exclusion Criteria: A history of influenza virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes in last three months Any prior administration of influenza vaccine in last six months Allergy to any component in the vaccine, especially for egg allergy Allergy history of any previous vaccination or drug Acute episodes of chronic illness or acute illness on the day of vaccination Received a live vaccine within fourteen days prior to receiving the vaccine, or received a subunit or inactivated vaccine within seven days Congenital or acquired immune deficiencies, or treatment with immunosuppressive agents, such as long-term treatment with systemic corticosteroids Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome) Asthma, required urgent treatment in last two years The blood products were received prior to the acceptance of the vaccine Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases History of epilepsy, convulsions, or a family history of psychosis Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy Plan to move or leave the area for an extended period of time before the end of the study Under anti-tb treatment Any prior administration of other research medicine/vaccine in last one month Women are pregnant or in the near future planned pregnancy or pregnancy test positive
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Dandan, MS
Phone
86-021-62750096-4210
Email
ddchen.sh@sinopharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hu Yuemei, PhD
Organizational Affiliation
Jiangsu Province Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suining County Center for Disease Control and Prevention
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou fang, BS
Facility Name
Xinyi County Center for Disease Control and Prevention
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Weiguang, BS

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial of A Quadrivalent Influenza Vaccine

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