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

NCT05245552 | Completed Phase 3

• 1 other identifier: PRO-QINF-3003
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Seasonal Influenza

Outcome Measures

Primary Outcomes (7)

• Immunogenicity index of seroconversion rate

  HI antibody seroconversion rate 28 days after full schedule immunization

  28 days after full schedule immunization

• Immunogenicity index of seroprotection rate

  HI antibody seroprotection rate 28 days after full schedule immunization

  28 days after full schedule immunization

• Immunogenicity index of GMT

  HI antibody GMT increase folds 28 days after full schedule immunization

  28 days after full schedule immunization

• Safety index of the incidence of adverse reaction

  Incidence of adverse reaction 0-28 days after each dose

  0-28 days after each dose

• Safety index of the incidence of adverse reaction

  Incidence of adverse reaction 0-7 days after each dose

  0-7 days after each dose

• 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

• 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 Outcomes (1)

• Safety index of the incidence of AESI

  Since the beginning of vaccination until 6 months after full course vaccination

Study Arms (5)

Safety group

EXPERIMENTAL

PhaseⅠ,30 subjects will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.

Biological: Quadrivalent influenza vaccine(0.25ml)

Experimental Group of quadrivalent influenza vaccine(0.25ml)

EXPERIMENTAL

1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.25ml) on the immunization schedule of day 0,28.

Biological: Quadrivalent influenza vaccine(0.25ml)

Experimental Group of quadrivalent influenza vaccine(0.5ml)

EXPERIMENTAL

1100 subjects phase III will receive two doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.

Biological: Quadrivalent influenza vaccine(0.5ml)

Control Group of trivalent influenza vaccine(BV)

ACTIVE COMPARATOR

550 subjects phase III will receive two doses of trivalent influenza vaccine(BV) on the immunization schedule of day 0,28.

Biological: Trivalent influenza vaccine(BV)

Control Group of trivalent influenza vaccine(BY)

ACTIVE COMPARATOR

550 subjects phase III will receive two doses of trivalent influenza vaccine(BY) on the immunization schedule of day 0,28.

Biological: Trivalent influenza vaccine(BY)

Interventions

Quadrivalent influenza vaccine(0.25ml) BIOLOGICAL

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.

Experimental Group of quadrivalent influenza vaccine(0.25ml); Safety group

Quadrivalent influenza vaccine(0.5ml) BIOLOGICAL

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.

Experimental Group of quadrivalent influenza vaccine(0.5ml)

Trivalent influenza vaccine(BV) BIOLOGICAL

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.

Control Group of trivalent influenza vaccine(BV)

Trivalent influenza vaccine(BY) BIOLOGICAL

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.

Control Group of trivalent influenza vaccine(BY)

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants aged 6-35 months;
• Proven vaccination certificate and birth certificate;
• The subjects' guardians can understand and voluntarily sign the informed consent form.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (4)

Huaiyin Center for Diseases Control and Prevention

Huai'an, Jiangsu, 223300, China

Location

Ganyu District Center for Disease Control and Prevention

Lianyungang, Jiangsu, 222100, China

Location

Donghai District Center for Disease Prevention and Control

Lianyungang, Jiangsu, 222300, China

Location

Binhai District Center for Disease Control and Prevention

Yancheng, Jiangsu, 224500, China

Location

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Hongxing Pan, Master

  Jiangsu Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: August 8, 2022
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CN (4)