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

Seasonal Influenza Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049927
• Other study ID #: PRO-QINF-3005
• Status: Recruiting
• Phase: Phase 3
• Start date: September 16, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: Sinovac Biotech Co., Ltd
• Contact: Lei Wang
• Phone: 18986142864
• Email: 372491281[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3300
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 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 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

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 njection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses 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 njection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses 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 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 vaccine on day 0, 28.

Locations

Country	Name	City	State
China	Huoqiu County Center for Disease Control and Prevention	Lu'an	Anhui
China	Zhushan County Center for Diseases Control and Prevention	Shiyan	Hubei
China	Laohekou Center for Disease Control and Prevention	Xiangyang	Hubei
China	Nanzhang County Center for Disease Prevention and Control	Xiangyang	Hubei
China	Digui County Center for Disease Control and Prevention	Yichang	Hubei

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	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.	28 days after full schedule immunization
Primary	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.	28 days after full schedule immunization
Primary	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.	28 days after full schedule immunization
Secondary	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	28 days after full schedule immunization
Secondary	Incidence of adverse reactions	Incidence of adverse reaction 0-30 days after each dose	0-30 days after each dose
Secondary	Incidence of adverse reactions	Incidence of adverse reaction 0-7 days after each dose	0-7 days after each dose
Secondary	Incidence of Serious adverse events	Incidence of serious adverse events from beginning of vaccination until 6 months after the last dose	Since the beginning of vaccination until 6 months after the last dose
Secondary	Incidence of AESI	Incidence of AESI since the beginning of vaccination until 6 months after the last dose	since the beginning of vaccination until 6 months after the last dose