A Clinical Trial of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old

NCT04997239 | Completed Phase 4

• 1 other identifier: PRO-QINF-4002
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine with that of 2 doses in vaccine-unprimed children aged 3-8 years old,to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children and to compare the immunogenicity and safety after 2 doses of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children.

Conditions

Seasonal Influenza

Outcome Measures

Primary Outcomes (7)

• Immunogenicity index of the seroconversion rate

  The seroconversion rate of each influenza strain after each dose of quadrivalent influenza vaccine

  28 days after the vaccination of the last dose

• Immunogenicity index of the seroprotective rate

  The seroprotective rate of each influenza strain after each dose of quadrivalent influenza vaccine

  28 days after the vaccination of the last dose

• Immunogenicity index of the GMT

  The GMT of each influenza strain after each dose of quadrivalent influenza vaccine

  28 days after the vaccination of the last dose

• Immunogenicity index of the GMI

  The GMI of each influenza strain after each dose of quadrivalent influenza vaccine

  28 days after the vaccination of the last dose

• Safety index of the incidence of adverse reactions

  The incidence of adverse reactions within 0-7 days after each dose

  From day 0 to day 7 after each dose vaccination

• Safety index of the incidence of adverse reactions

  The incidence of adverse reactions within 0-28 days after each dose

  From day 0 to day 28 after each dose vaccination

• Safety index of the incidence of serious adverse events(SAEs)

  The incidence of serious adverse events from the beginning of vaccination to 28 days after the last dose

  From the beginning of the vaccination to 28 days after the whole-schedule vaccination

Study Arms (3)

Experimental Group ：Vaccine-unprimed subjects with two doses

EXPERIMENTAL

200 vaccine-unprimed children will receive two doses of quadrivalent influenza vaccine on the immunization schedule of day 0,28.

Biological: Two doses of quadrivalent influenza vaccine

Experimental Group ：Vaccine-unprimed subjects with one dose

EXPERIMENTAL

200 vaccine-unprimed children will receive one dose of quadrivalent influenza vaccine.

Biological: One dose of quadrivalent influenza vaccine

Experimental Group：Vaccine-primed subjects with one dose

EXPERIMENTAL

200 vaccine-primed children will receive one dose of quadrivalent influenza vaccine.

Biological: One dose of quadrivalent influenza vaccine

Interventions

Two doses of quadrivalent influenza vaccine BIOLOGICAL

15ug 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 administation is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.

Experimental Group ：Vaccine-unprimed subjects with two doses

One dose of quadrivalent influenza vaccine BIOLOGICAL

15ug 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 administation is Intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.

Experimental Group ：Vaccine-unprimed subjects with one dose; Experimental Group：Vaccine-primed subjects with one dose

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 3-8 years;
• The subjects' guardians can understand and voluntarily sign the informed consent form;
• Proven legal identity.

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;
• 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.;
• Autoimmune disease or immunodeficiency / immunosuppression;
• Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
• Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
• 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;
• History of drug abuse;
• Receipt of blood products within in the past 3 months;
• Receipt of other investigational drugs in the past 30 days;
• Receipt of inactivated or subunit vaccines in the past 7 days;
• Acute diseases or acute exacerbation of chronic diseases in the past 7 days;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Huaiyin Center for Disease Control and Prevention

Huai'an, Jiangsu, 223300, 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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 9, 2021
• Study Start: October 10, 2021
• Primary Completion: October 30, 2021
• Study Completion: November 20, 2021
• Last Updated: August 11, 2022

Record last verified: 2021-07

Locations

CN (1)