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

Seasonal Influenza Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245552
• Other study ID #: PRO-QINF-3003
• Status: Recruiting
• Phase: Phase 3
• Start date: August 8, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: October 2023
• Source: Sinovac Biotech Co., Ltd
• Contact: Hongxing Pan, Master
• Phone: 18118996996
• Email: panhongxing[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3330
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

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 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Huaiyin Center for Diseases Control and Prevention	Huai'an	Jiangsu
China	Donghai District Center for Disease Prevention and Control	Lianyungang	Jiangsu
China	Ganyu District Center for Disease Control and Prevention	Lianyungang	Jiangsu
China	Binhai District Center for Disease Control and Prevention	Yancheng	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity index of seroconversion rate	HI antibody seroconversion rate 28 days after full schedule immunization	28 days after full schedule immunization
Primary	Immunogenicity index of seroprotection rate	HI antibody seroprotection rate 28 days after full schedule immunization	28 days after full schedule immunization
Primary	Immunogenicity index of GMT	HI antibody GMT increase folds 28 days after full schedule immunization	28 days after full schedule immunization
Primary	Safety index of the incidence of adverse reaction	Incidence of adverse reaction 0-28 days after each dose	0-28 days after each dose
Primary	Safety index of the incidence of adverse reaction	Incidence of adverse reaction 0-7 days after each dose	0-7 days after each dose
Primary	Safety index of the incidence of abnormal blood biochemical indexes	The incidence of abnormal blood biochemical indexes 3 days after each dose	3 days after each dose
Primary	Safety index of the incidence of SAE	Incidence of SAE since the beginning of vaccination until 6 months after full course vaccination	Since the beginning of vaccination until 6 months after full course vaccination
Secondary	Safety index of the incidence of AESI	Incidence of AESI since the beginning of vaccination until 6 months after full course vaccination	Since the beginning of vaccination until 6 months after full course vaccination