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

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ClinicalTrials.gov Identifier: NCT06049927
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : October 2, 2023
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Seasonal Influenza Biological: Quadrivalent influenza vaccine(0.25ml) Biological: Quadrivalent influenza vaccine(0.5ml) Biological: Trivalent influenza vaccine(BV) Biological: Trivalent influenza vaccine(BY) Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : September 16, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Group of quadrivalent influenza vaccine(0.25ml)
1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.25ml) according to the immunization schedule of day 0,28
 Biological: Quadrivalent influenza vaccine(0.25ml)
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.
Experimental: Experimental Group of quadrivalent influenza vaccine(0.5ml)
1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.5ml) according to the immunization schedule of day 0,28
 Biological: Quadrivalent influenza vaccine(0.5ml)
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.
Active Comparator: Control Group of trivalent influenza vaccine(BV)
550 subjects phase III will receive two doses of trivalent influenza vaccine(BV) according to the immunization schedule of day 0,28.
 Biological: Trivalent influenza vaccine(BV)
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.
Active Comparator: Control Group of trivalent influenza vaccine(BY)
550 subjects phase III will receive two doses of trivalent influenza vaccine(BY) according to the immunization schedule of day 0,28.
 Biological: Trivalent influenza vaccine(BY)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Seroconversion rates of HI antibody [ Time Frame: 28 days after full schedule immunization ]
    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.

  2. Geometric Mean Titers (GMTs) of HI antibody [ Time Frame: 28 days after full schedule immunization ]
    Anti-influenza antibody levels were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.

  3. Number of Participants With Seroprotection to Influenza Vaccine Antigens [ Time Frame: 28 days after full schedule immunization ]
    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 :
  1. GMIs of HI antibody [ Time Frame: 28 days after full schedule immunization ]
    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

  2. Incidence of adverse reactions [ Time Frame: 0-30 days after each dose ]
    Incidence of adverse reaction 0-30 days after each dose

  3. Incidence of adverse reactions [ Time Frame: 0-7 days after each dose ]
    Incidence of adverse reaction 0-7 days after each dose

  4. Incidence of Serious adverse events [ Time Frame: Since the beginning of vaccination until 6 months after the last dose ]
    Incidence of serious adverse events from beginning of vaccination until 6 months after the last dose

  5. Incidence of AESI [ Time Frame: since the beginning of vaccination until 6 months after the last dose ]
    Incidence of AESI since the beginning of vaccination until 6 months after the last dose


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049927


Contacts
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Contact: Lei Wang 18986142864 372491281@qq.com

Locations
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China, Anhui
Huoqiu County Center for Disease Control and Prevention Not yet recruiting
Lu'an, Anhui, China, 237400
Contact: Tao Wang    18905644963    2544285048@qq.com   
China, Hubei
Zhushan County Center for Diseases Control and Prevention Recruiting
Shiyan, Hubei, China, 442200
Contact: Xianhong Zeng       568235719@qq.com   
Nanzhang County Center for Disease Prevention and Control Recruiting
Xiangyang, Hubei, China, 441500
Contact: Chujun Chen    15671486908    894578445@qq.com   
Laohekou Center for Disease Control and Prevention Recruiting
Xiangyang, Hubei, China, 441800
Contact: Anguo Li    15072215220      
Contact       568235719@qq.com   
Digui County Center for Disease Control and Prevention Recruiting
Yichang, Hubei, China, 443600
Contact: Mingzhao Li    13469837136    309223049@qq.com   
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
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Principal Investigator: Lei Wang Hubei Provincial Center for Disease Prevention and Control
Principal Investigator: Jihai Tang Anhui Provincial Center for Disease Prevention and Control
More Information
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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT06049927    
Other Study ID Numbers: PRO-QINF-3005
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: October 2, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs