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Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)

Primary Purpose

Seasonal Influenza

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Quadrivalent influenza vaccine

Trivalent influenza vaccine (contains B/Victoria strain)

Trivalent influenza vaccine (contains B/Yamagata strain)

About this trial

This is an interventional prevention trial for Seasonal Influenza focused on measuring Influenza Vaccine, Quadrivalent, Trivalent

Eligibility Criteria

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

Inclusion Criteria:

Healthy volunteers aged ≥3 years;
Proven legal identity;
Participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;

Exclusion Criteria:

Prior vaccination with influenza vaccine of the current year;
History of influenza within 6 months prior to study entry;
Axillary temperature > 37.0 °C;
History of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.;
Serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.;
Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
History of asthma, thyroidectomy, angioedema, diabetes or malignancy;
No spleen, or functional no spleen, or splenectomy.

Sites / Locations

Guanyun Center for Disease Control and Prevention
Pizhou Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group-phase I

Experimental group-phase III

Control group-1-phase III

Control group-2-phase III

Arm Description

Quadrivalent influenza vaccine

Trivalent influenza vaccine (contains B/Victoria strain)

Trivalent influenza vaccine (contains B/Yamagata strain)

Outcomes

Primary Outcome Measures

The lower limit of 95% confidence intervals (95%CI) of the ratio of geometric mean titer of hemagglutination inhibition (HI) antibody titer (experimental group/control group)≥2/3.

Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines

The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%

Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines

Secondary Outcome Measures

The lower limit of 95%CI of the ratio of GMT(experimental group/control group)>1.5 .

Immunogenicity index, One of the standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type

The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%

Immunogenicity index, Another standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type

The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged 3-59 years≥40%

Immunogenicity index

The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged over 60 years≥30%

Immunogenicity index

The seroprotective rate (HI antibody titer≥1:40) in the subjects aged 3-59 years ≥70%

Immunogenicity index

The seroprotective rate (HI antibody titer≥1:40) in the subjects aged over 60 years ≥60%

Immunogenicity index

The geometric mean increase (GMI) in the subjects aged 3-59 years >2.5

Immunogenicity index

The geometric mean increase (GMI) in the subjects aged over 60 years >2.0

Immunogenicity index

The lower limit of 95%CI of the ratio of GMT(experimental group/control group)≥2/3, in the subjects whose pre-immune HI antibody titer<1:40

Immunogenicity index

The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%, in the subjects whose pre-immune HI antibody titer<1:40

Immunogenicity index

The incidence of the solicited local and general adverse reactions on day 0-7

Safety index, The adverse reactions refers to the adverse events which considered related to the vaccination

The incidence of the unsolicited adverse events on day 0-28

Safety Index

The incidence of the serious adverse events within 6 months after the injection

Safety Index

Full Information

NCT ID

NCT03853993

First Posted

February 21, 2019

Last Updated

February 25, 2019

Sponsor

Sinovac Biotech Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03853993

Brief Title

Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)

Official Title

Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged Over 3 Years.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

January 23, 2018 (Actual)

Primary Completion Date

August 17, 2018 (Actual)

Study Completion Date

October 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinovac Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged over 3 years

Detailed Description

This study is a phase I& III clinical trial. Phase I is open-labelled, and phase III is randomized, double-blind, active-controlled. The purpose of this study is to evaluate the safety and immunogenicity of the quadrivalent influenza vaccine (QIV) (experimental vaccine) manufactured by Sinovac Biotech Co., Ltd in subjects aged over 3 years. In phase I, 60 volunteers received single dose QIV (15µg/0.5ml). In phase III, 2320 volunteers were assigned to receive single dose QIV (15µg/0.5ml) or two commercial trivalent influenza vaccines (TIVs) (15µg/0.5ml) in a ratio of 2:1:1. The commercial TIVs were also manufactured by Sinovac Biotech Co., Ltd.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Influenza

Keywords

Influenza Vaccine, Quadrivalent, Trivalent

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

The phase I clinical trial has single arm, and the phase III clinical trial has 3 parallel arms.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2380 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group-phase I

Arm Type

Experimental

Arm Description

Quadrivalent influenza vaccine

Arm Title

Experimental group-phase III

Arm Type

Experimental

Arm Description

Quadrivalent influenza vaccine

Arm Title

Control group-1-phase III

Arm Type

Active Comparator

Arm Description

Trivalent influenza vaccine (contains B/Victoria strain)

Arm Title

Control group-2-phase III

Arm Type

Active Comparator

Arm Description

Trivalent influenza vaccine (contains B/Yamagata strain)

Intervention Type

Biological

Intervention Name(s)

Quadrivalent influenza vaccine

Intervention Description

Received single dose QIV (15µg/0.5ml)

Intervention Type

Biological

Intervention Name(s)

Trivalent influenza vaccine (contains B/Victoria strain)

Intervention Description

Received single dose TIV which contains B/Victoria strain (15µg/0.5ml)

Intervention Type

Biological

Intervention Name(s)

Trivalent influenza vaccine (contains B/Yamagata strain)

Intervention Description

Received single dose TIV which contains B/Yamagata strain (15µg/0.5ml)

Primary Outcome Measure Information:

Title

The lower limit of 95% confidence intervals (95%CI) of the ratio of geometric mean titer of hemagglutination inhibition (HI) antibody titer (experimental group/control group)≥2/3.

Description

Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines

Time Frame

28 days after the injection

Title

The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%

Description

Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines

Time Frame

28 days after the injection

Secondary Outcome Measure Information:

Title

The lower limit of 95%CI of the ratio of GMT(experimental group/control group)>1.5 .

Description

Immunogenicity index, One of the standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type

Time Frame

28 days after the injection

Title

The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%

Description

Immunogenicity index, Another standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type

Time Frame

28 days after the injection

Title

The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged 3-59 years≥40%

Description

Immunogenicity index

Time Frame

28 days after the injection

Title

The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged over 60 years≥30%

Description

Immunogenicity index

Time Frame

28 days after the injection

Title

The seroprotective rate (HI antibody titer≥1:40) in the subjects aged 3-59 years ≥70%

Description

Immunogenicity index

Time Frame

28 days after the injection

Title

The seroprotective rate (HI antibody titer≥1:40) in the subjects aged over 60 years ≥60%

Description

Immunogenicity index

Time Frame

28 days after the injection

Title

The geometric mean increase (GMI) in the subjects aged 3-59 years >2.5

Description

Immunogenicity index

Time Frame

28 days after the injection

Title

The geometric mean increase (GMI) in the subjects aged over 60 years >2.0

Description

Immunogenicity index

Time Frame

28 days after the injection

Title

The lower limit of 95%CI of the ratio of GMT(experimental group/control group)≥2/3, in the subjects whose pre-immune HI antibody titer<1:40

Description

Immunogenicity index

Time Frame

28 days after the injection

Title

The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%, in the subjects whose pre-immune HI antibody titer<1:40

Description

Immunogenicity index

Time Frame

28 days after the injection

Title

The incidence of the solicited local and general adverse reactions on day 0-7

Description

Safety index, The adverse reactions refers to the adverse events which considered related to the vaccination

Time Frame

0-7 days after the injection

Title

The incidence of the unsolicited adverse events on day 0-28

Description

Safety Index

Time Frame

0-28 days after the injection

Title

The incidence of the serious adverse events within 6 months after the injection

Description

Safety Index

Time Frame

Within 6 months after the injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy volunteers aged ≥3 years; Proven legal identity; Participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment; Exclusion Criteria: Prior vaccination with influenza vaccine of the current year; History of influenza within 6 months prior to study entry; Axillary temperature > 37.0 °C; History of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.; Serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.; Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness; Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry; History of asthma, thyroidectomy, angioedema, diabetes or malignancy; No spleen, or functional no spleen, or splenectomy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuemei Hu, Bachelor

Organizational Affiliation

Jiangsu Province Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guanyun Center for Disease Control and Prevention

City

Lianyungang

State/Province

Jiangsu

ZIP/Postal Code

222200

Country

China

Facility Name

Pizhou Center for Disease Control and Prevention

City

Pizhou

State/Province

Jiangsu

ZIP/Postal Code

221300

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

32732142

Citation

Chu K, Xu K, Tang R, Tian X, Hu J, Yang T, Li C, Hu Y, Zeng G. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: A randomized, double-blind, controlled phase III study in healthy population aged >/=3 years. Vaccine. 2020 Aug 18;38(37):5940-5946. doi: 10.1016/j.vaccine.2020.06.071. Epub 2020 Jul 27.

Results Reference

derived

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Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)

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