Clinical trial
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.
Name
PRO-QINF-3003
Description
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.
Trial arms
Trial start
2022-08-08
Estimated PCD
2023-12-20
Trial end
2023-12-20
Status
Recruiting
Phase
Early phase I
Treatment
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 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.
Arms:
Experimental Group of quadrivalent influenza vaccine(0.25ml), Safety group
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 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.
Arms:
Experimental Group of quadrivalent influenza vaccine(0.5ml)
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 of quadrivalent influenza vaccine on day 0, 28.
Arms:
Control Group of trivalent influenza vaccine(BV)
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 of quadrivalent influenza vaccine on day 0, 28.
Arms:
Control Group of trivalent influenza vaccine(BY)
Size
3330
Primary endpoint
Immunogenicity index of seroconversion rate
28 days after full schedule immunization
Immunogenicity index of seroprotection rate
28 days after full schedule immunization
Immunogenicity index of GMT
28 days after full schedule immunization
Safety index of the incidence of adverse reaction
0-28 days after each dose
Safety index of the incidence of adverse reaction
0-7 days after each dose
Safety index of the incidence of abnormal blood biochemical indexes
3 days after each dose
Safety index of the incidence of SAE
Since the beginning of vaccination until 6 months after full course vaccination
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 3330, 'type': 'ESTIMATED'}}
Updated at
2023-10-10
1 organization
2 products
1 indication
Organization
Sinovac BiotechIndication
Seasonal InfluenzaProduct
Trivalent influenza vaccine