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

Last updated: August 8, 2025
Sponsor: Sinovac Biotech Co., Ltd
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Quadrivalent influenza vaccine(0.5ml)

Quadrivalent influenza vaccine(0.25ml)

Trivalent influenza vaccine(BV)

Clinical Study ID

NCT06049927
PRO-QINF-3005
  • Ages 6-35
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy infants aged 6-35 months;

  • Proven vaccination certificate and birth certificate;

  • The subjects' guardians can understand and voluntarily sign the informed consentform.

Exclusion

Exclusion Criteria:

  • Received any circulating seasonal influenza vaccine prior to enrollment or had aninfluenza 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 adversereactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma;

  • Congenital malformations or developmental disorders, genetic defects, severemalnutrition, etc.;

  • Severe chronic diseases(Such as down syndrome, diabetes, sickle cell anaemia orneurological disorders);

  • Severe neurological disease (epilepsy, convulsions or convulsions) or mentalillness;

  • 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, aspleniaor splenectomy resulting from any condition;

  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulationfactors, blood coagulopathy, abnormal platelets) or obvious bruising or bloodcoagulation;

  • Continuous use of corticosteroids or other immunosuppressive agents for ≥ 14 dayswithin the past 6 months (excluding allergic rhinitis corticosteroid spray therapy,acute noncomplicated dermatitis superficial corticosteroid therapy) and cytotoxictherapy 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 arenot suitable for participating in the clinical trial

Study Design

Total Participants: 3300
Treatment Group(s): 4
Primary Treatment: Quadrivalent influenza vaccine(0.5ml)
Phase: 3
Study Start date:
September 16, 2023
Estimated Completion Date:
May 23, 2024

Study 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.

Connect with a study center

  • Huoqiu County Center for Disease Control and Prevention

    Lu'an, Anhui 237400
    China

    Site Not Available

  • Zhushan County Center for Diseases Control and Prevention

    Shiyan, Hubei 442200
    China

    Site Not Available

  • Laohekou Center for Disease Control and Prevention

    Xiangyang, Hubei 441800
    China

    Site Not Available

  • Nanzhang County Center for Disease Prevention and Control

    Xiangyang, Hubei 441500
    China

    Site Not Available

  • Digui County Center for Disease Control and Prevention

    Yichang, Hubei 443600
    China

    Site Not Available

  • Zigui County Center for Disease Control and Prevention

    Yichang, Hubei 443600
    China

    Site Not Available

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