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A Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months

Primary Purpose

Seasonal Influenza

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Quadrivalent influenza vaccine(0.25ml)

Quadrivalent influenza vaccine(0.5ml)

Trivalent influenza vaccine(BV)

Trivalent influenza vaccine(BY)

About this trial

This is an interventional prevention trial for Seasonal Influenza

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy infants aged 6-35 months;
Proven vaccination certificate and birth certificate;
The subjects' guardians can understand and voluntarily sign the informed consent form.

Exclusion Criteria:

Received any circulating seasonal influenza vaccine prior to enrollment or had an influenza vaccine schedule during the study;
Suffering from seasonal influenza in the past 6 moths;
Axillary temperature >37.0°C;
History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
Severe chronic diseases(Such as down syndrome, diabetes, sickle cell anaemia or neurological disorders);
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Autoimmune disease or immunodeficiency / immunosuppression;
Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
Acute diseases or acute exacerbation of chronic diseases in the past 3 days;
Receipt of blood products within in the past 3 months;
Receipt of other investigational drugs in the past 30 days;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Participated in other clinical trials before enrollment and in the follow-up period, or plans to participate in other clinical trials during the clinical trial;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial

Sites / Locations

Huaiyin Center for Diseases Control and PreventionRecruiting
Ganyu District Center for Disease Control and PreventionRecruiting
Donghai District Center for Disease Prevention and ControlRecruiting
Binhai District Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Safety group

Experimental Group of quadrivalent influenza vaccine(0.25ml)

Experimental Group of quadrivalent influenza vaccine(0.5ml)

Control Group of trivalent influenza vaccine(BV)

Control Group of trivalent influenza vaccine(BY)

Arm Description

PhaseⅠ,30 subjects will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.

1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.25ml) on the immunization schedule of day 0,28.

1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.

550 subjects phase III will receive two doses of trivalent influenza vaccine(BV) on the immunization schedule of day 0,28.

550 subjects phase III will receive two doses of trivalent influenza vaccine(BY) on the immunization schedule of day 0,28.

Outcomes

Primary Outcome Measures

Immunogenicity index of seroconversion rate

HI antibody seroconversion rate 28 days after full schedule immunization

Immunogenicity index of seroprotection rate

HI antibody seroprotection rate 28 days after full schedule immunization

Immunogenicity index of GMT

HI antibody GMT increase folds 28 days after full schedule immunization

Safety index of the incidence of adverse reaction

Incidence of adverse reaction 0-28 days after each dose

Safety index of the incidence of adverse reaction

Incidence of adverse reaction 0-7 days after each dose

Safety index of the incidence of abnormal blood biochemical indexes

The incidence of abnormal blood biochemical indexes 3 days after each dose

Safety index of the incidence of SAE

Incidence of SAE since the beginning of vaccination until 6 months after full course vaccination

Secondary Outcome Measures

Safety index of the incidence of AESI

Incidence of AESI since the beginning of vaccination until 6 months after full course vaccination

Full Information

NCT ID

NCT05245552

First Posted

February 8, 2022

Last Updated

October 7, 2023

Sponsor

Sinovac Biotech Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05245552

Brief Title

A Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months

Official Title

An 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 6 to 35months.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 8, 2022 (Actual)

Primary Completion Date

December 20, 2023 (Anticipated)

Study Completion Date

December 20, 2023 (Anticipated)

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 study of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co., Ltd will conduct in two phases,the phaseⅠclinical trial of the study will be open-label design,and the phase III clinical trial of the study will be randomized, double-blind, active controlled design.the purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged 6 to 35 months.

Detailed Description

This study of quadrivalent influenza vaccine will be open-label design in phase Ⅰ and randomized, double-blind, active controlled design in phase III.The quadrivalent influenza vaccine was manufactured by Sinovac Biotech Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine(0.25ml and 0.5ml) manufactured by Sinovac Biotech Co., Ltd in healthy infants aged from 6 to 35 months. A total of 3330 subjects including 30 subjects in phase Ⅰ and 3300 subjects in phase III will be enrolled. The subjects in phase Ⅰ will receive 2 doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.The subjects in phase III will be randomly assigned to 4 groups in a 2:2:1:1 ratio and subjects will receive two doses of quadrivalent influenza vaccine(0.25ml or 0.5ml) or trivalent influenza vaccine(BV or BY), respectively,on the immunization schedule of day 0,28 in each group.

6. Conditions and Keywords

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

Seasonal Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Safety group

Arm Type

Experimental

Arm Description

PhaseⅠ,30 subjects will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.

Arm Title

Experimental Group of quadrivalent influenza vaccine(0.25ml)

Arm Type

Experimental

Arm Description

1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.25ml) on the immunization schedule of day 0,28.

Arm Title

Experimental Group of quadrivalent influenza vaccine(0.5ml)

Arm Type

Experimental

Arm Description

1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.

Arm Title

Control Group of trivalent influenza vaccine(BV)

Arm Type

Active Comparator

Arm Description

550 subjects phase III will receive two doses of trivalent influenza vaccine(BV) on the immunization schedule of day 0,28.

Arm Title

Control Group of trivalent influenza vaccine(BY)

Arm Type

Active Comparator

Arm Description

550 subjects phase III will receive two doses of trivalent influenza vaccine(BY) on the immunization schedule of day 0,28.

Intervention Type

Biological

Intervention Name(s)

Quadrivalent influenza vaccine(0.25ml)

Intervention Description

7.5 ug hemagglutinin (HA) of each of the four influenza strains in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.

Intervention Type

Biological

Intervention Name(s)

Quadrivalent influenza vaccine(0.5ml)

Intervention Description

15 ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.

Intervention Type

Biological

Intervention Name(s)

Trivalent influenza vaccine(BV)

Intervention Description

7.5μg inactivated influenza antigen (H1N1, H3N2, Victoria) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.

Intervention Type

Biological

Intervention Name(s)

Trivalent influenza vaccine(BY)

Intervention Description

7.5μg inactivated influenza antigen (H1N1, H3N2, and Yamagata) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.

Primary Outcome Measure Information:

Title

Immunogenicity index of seroconversion rate

Description

HI antibody seroconversion rate 28 days after full schedule immunization

Time Frame

28 days after full schedule immunization

Title

Immunogenicity index of seroprotection rate

Description

HI antibody seroprotection rate 28 days after full schedule immunization

Time Frame

28 days after full schedule immunization

Title

Immunogenicity index of GMT

Description

HI antibody GMT increase folds 28 days after full schedule immunization

Time Frame

28 days after full schedule immunization

Title

Safety index of the incidence of adverse reaction

Description

Incidence of adverse reaction 0-28 days after each dose

Time Frame

0-28 days after each dose

Title

Safety index of the incidence of adverse reaction

Description

Incidence of adverse reaction 0-7 days after each dose

Time Frame

0-7 days after each dose

Title

Safety index of the incidence of abnormal blood biochemical indexes

Description

The incidence of abnormal blood biochemical indexes 3 days after each dose

Time Frame

3 days after each dose

Title

Safety index of the incidence of SAE

Description

Incidence of SAE since the beginning of vaccination until 6 months after full course vaccination

Time Frame

Since the beginning of vaccination until 6 months after full course vaccination

Secondary Outcome Measure Information:

Title

Safety index of the incidence of AESI

Description

Incidence of AESI since the beginning of vaccination until 6 months after full course vaccination

Time Frame

Since the beginning of vaccination until 6 months after full course vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

35 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy infants aged 6-35 months; Proven vaccination certificate and birth certificate; The subjects' guardians can understand and voluntarily sign the informed consent form. Exclusion Criteria: Received any circulating seasonal influenza vaccine prior to enrollment or had an influenza vaccine schedule during the study; Suffering from seasonal influenza in the past 6 moths; Axillary temperature >37.0°C; History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Severe chronic diseases(Such as down syndrome, diabetes, sickle cell anaemia or neurological disorders); Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; Autoimmune disease or immunodeficiency / immunosuppression; Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition; Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; Acute diseases or acute exacerbation of chronic diseases in the past 3 days; Receipt of blood products within in the past 3 months; Receipt of other investigational drugs in the past 30 days; Receipt of attenuated live vaccines in the past 14 days; Receipt of inactivated or subunit vaccines in the past 7 days; Participated in other clinical trials before enrollment and in the follow-up period, or plans to participate in other clinical trials during the clinical trial; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hongxing Pan, Master

Phone

18118996996

panhongxing@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hongxing Pan, Master

Organizational Affiliation

Jiangsu Provincial Center for Disease Prevention and Control

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huaiyin Center for Diseases Control and Prevention

City

Huai'an

State/Province

Jiangsu

ZIP/Postal Code

223300

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jingliang Wu

Phone

13915112232

493316307@qq.com

Facility Name

Ganyu District Center for Disease Control and Prevention

City

Lianyungang

State/Province

Jiangsu

ZIP/Postal Code

222100

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sheng Liu, Bachelor

Phone

13851203882

gyjkls@163.com

Facility Name

Donghai District Center for Disease Prevention and Control

City

Lianyungang

State/Province

Jiangsu

ZIP/Postal Code

222300

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoqin Chen, Bachelor

Phone

15950778638

525056533@qq.com

Facility Name

Binhai District Center for Disease Control and Prevention

City

Yancheng

State/Province

Jiangsu

ZIP/Postal Code

224500

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoshan Wang

Phone

15351514269

1018896715@qq.com

12. IPD Sharing Statement

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A Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months

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