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

Sponsor

Sinovac Biotech Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT03853993

Collaborator

(none)

2,380

Enrollment

Locations

Arms

8.5

Actual Duration (Months)

1190

Patients Per Site

140.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Seasonal Influenza	Biological: Quadrivalent influenza vaccine Biological: Trivalent influenza vaccine (contains B/Victoria strain) Biological: Trivalent influenza vaccine (contains B/Yamagata strain)	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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.

Actual Study Start Date :

Jan 23, 2018

Actual Primary Completion Date :

Aug 17, 2018

Actual Study Completion Date :

Oct 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group-phase I Quadrivalent influenza vaccine	Biological: Quadrivalent influenza vaccine Received single dose QIV (15µg/0.5ml)
Experimental: Experimental group-phase III Quadrivalent influenza vaccine	Biological: Quadrivalent influenza vaccine Received single dose QIV (15µg/0.5ml)
Active Comparator: Control group-1-phase III Trivalent influenza vaccine (contains B/Victoria strain)	Biological: Trivalent influenza vaccine (contains B/Victoria strain) Received single dose TIV which contains B/Victoria strain (15µg/0.5ml)
Active Comparator: Control group-2-phase III Trivalent influenza vaccine (contains B/Yamagata strain)	Biological: Trivalent influenza vaccine (contains B/Yamagata strain) Received single dose TIV which contains B/Yamagata strain (15µg/0.5ml)

Outcome Measures

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. [28 days after the injection]
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% [28 days after the injection]
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 . [28 days after the injection]
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% [28 days after the injection]
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% [28 days after the injection]
Immunogenicity index
The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged over 60 years≥30% [28 days after the injection]
Immunogenicity index
The seroprotective rate (HI antibody titer≥1:40) in the subjects aged 3-59 years ≥70% [28 days after the injection]
Immunogenicity index
The seroprotective rate (HI antibody titer≥1:40) in the subjects aged over 60 years ≥60% [28 days after the injection]
Immunogenicity index
The geometric mean increase (GMI) in the subjects aged 3-59 years >2.5 [28 days after the injection]
Immunogenicity index
The geometric mean increase (GMI) in the subjects aged over 60 years >2.0 [28 days after the injection]
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 [28 days after the injection]
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 [28 days after the injection]
Immunogenicity index
The incidence of the solicited local and general adverse reactions on day 0-7 [0-7 days after the injection]
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 [0-28 days after the injection]
Safety Index
The incidence of the serious adverse events within 6 months after the injection [Within 6 months after the injection]
Safety Index

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guanyun Center for Disease Control and Prevention	Lianyungang	Jiangsu	China	222200
2	Pizhou Center for Disease Control and Prevention	Pizhou	Jiangsu	China	221300

Sponsors and Collaborators

Sinovac Biotech Co., Ltd

Investigators

Principal Investigator: Yuemei Hu, Bachelor, Jiangsu Province Center for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sinovac Biotech Co., Ltd

ClinicalTrials.gov Identifier:

NCT03853993

Other Study ID Numbers:

PRO-QINF-3001

First Posted:

Feb 26, 2019

Last Update Posted:

Feb 27, 2019

Last Verified:

Feb 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sinovac Biotech Co., Ltd

Influenza Vaccine

Quadrivalent

Trivalent

Additional relevant MeSH terms:

Influenza, Human

Vaccines

Study Results

No Results Posted as of Feb 27, 2019