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A Phase III 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)
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

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 allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma; 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 (such as systemic lupus erythematosus) or immunodeficiency / immunosuppression (such as HIV, after organ transplantation) 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; Continuous use of corticosteroids or other immunosuppressive agents for ≥ 14 days within the past 6 months (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) and cytotoxic 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

  • Huoqiu County Center for Disease Control and Prevention
  • Zhushan County Center for Diseases Control and PreventionRecruiting
  • Nanzhang County Center for Disease Prevention and ControlRecruiting
  • Laohekou Center for Disease Control and PreventionRecruiting
  • Digui County Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

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

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

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

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

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

Outcomes

Primary Outcome Measures

Seroconversion rates of HI antibody
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer <1:10 and post-vaccination titer ≥1:40, and Significant increase was defined as pre-vaccination titer≥1:40 and ≥ 4-fold increase of post-vaccination titer.
Geometric Mean Titers (GMTs) of HI antibody
Anti-influenza antibody levels were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer ≥1:40 at pre-vaccination and at post-final vaccination.

Secondary Outcome Measures

GMIs of HI antibody
Anti-influenza antibody were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata. GMI is the increase fold of GMT post vaccination compared with pre vaccination
Incidence of adverse reactions
Incidence of adverse reaction 0-30 days after each dose
Incidence of adverse reactions
Incidence of adverse reaction 0-7 days after each dose
Incidence of Serious adverse events
Incidence of serious adverse events from beginning of vaccination until 6 months after the last dose
Incidence of AESI
Incidence of AESI since the beginning of vaccination until 6 months after the last dose

Full Information

First Posted
September 15, 2023
Last Updated
September 29, 2023
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06049927
Brief Title
A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
Official Title
An 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
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the Immunogenicity and safety of the vaccine.
Detailed Description
A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective 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 3300 subjects will be enrolled. The subjects 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, according to 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3300 (Anticipated)

8. Arms, Groups, and Interventions

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) according to 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) according to 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) according to 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) according to 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 njection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses 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 njection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses 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 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 vaccine on day 0, 28.
Primary Outcome Measure Information:
Title
Seroconversion rates of HI antibody
Description
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer <1:10 and post-vaccination titer ≥1:40, and Significant increase was defined as pre-vaccination titer≥1:40 and ≥ 4-fold increase of post-vaccination titer.
Time Frame
28 days after full schedule immunization
Title
Geometric Mean Titers (GMTs) of HI antibody
Description
Anti-influenza antibody levels were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Time Frame
28 days after full schedule immunization
Title
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Description
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer ≥1:40 at pre-vaccination and at post-final vaccination.
Time Frame
28 days after full schedule immunization
Secondary Outcome Measure Information:
Title
GMIs of HI antibody
Description
Anti-influenza antibody were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata. GMI is the increase fold of GMT post vaccination compared with pre vaccination
Time Frame
28 days after full schedule immunization
Title
Incidence of adverse reactions
Description
Incidence of adverse reaction 0-30 days after each dose
Time Frame
0-30 days after each dose
Title
Incidence of adverse reactions
Description
Incidence of adverse reaction 0-7 days after each dose
Time Frame
0-7 days after each dose
Title
Incidence of Serious adverse events
Description
Incidence of serious adverse events from beginning of vaccination until 6 months after the last dose
Time Frame
Since the beginning of vaccination until 6 months after the last dose
Title
Incidence of AESI
Description
Incidence of AESI since the beginning of vaccination until 6 months after the last dose
Time Frame
since the beginning of vaccination until 6 months after the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
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 allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma; 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 (such as systemic lupus erythematosus) or immunodeficiency / immunosuppression (such as HIV, after organ transplantation) 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; Continuous use of corticosteroids or other immunosuppressive agents for ≥ 14 days within the past 6 months (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) and cytotoxic 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
Lei Wang
Phone
18986142864
Email
372491281@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Wang
Organizational Affiliation
Hubei Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jihai Tang
Organizational Affiliation
Anhui Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huoqiu County Center for Disease Control and Prevention
City
Lu'an
State/Province
Anhui
ZIP/Postal Code
237400
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Wang
Phone
18905644963
Email
2544285048@qq.com
Facility Name
Zhushan County Center for Diseases Control and Prevention
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianhong Zeng
Email
568235719@qq.com
Facility Name
Nanzhang County Center for Disease Prevention and Control
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chujun Chen
Phone
15671486908
Email
894578445@qq.com
Facility Name
Laohekou Center for Disease Control and Prevention
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441800
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anguo Li
Phone
15072215220
Email
568235719@qq.com
Facility Name
Digui County Center for Disease Control and Prevention
City
Yichang
State/Province
Hubei
ZIP/Postal Code
443600
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingzhao Li
Phone
13469837136
Email
309223049@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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