To Identify the Immunogenicity and Safety of QIV in Children Aged 3-8 Years

NCT05389137 | Unknown Phase 4 DMC

• 1 other identifier: WIBP2021007
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the immunogenicity and safety of quadrivalent split influenza virus vaccine in children aged 3-8 years with two doses and one dose. This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study. Sample size and test grouping: In this study, a total of 360 subjects were enrolled in a self-controlled trial design. In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), experimental group 2 (one dose of influenza vaccine previously) and experimental group 3 (two or more doses of influenza vaccine previously), with 120 cases in each experimental group. All subjects received one dose of tetravalent influenza virus lysis vaccine on day 0,28 for immunogenicity and safety observation.

Conditions

Influenza

Outcome Measures

Primary Outcomes (7)

• Seroconversion Rate (SCR)

  Seroconversion Rate (SCR) of HI antibodies of 4 vaccine strain types in all subjects

  28 days after the first dose of trial vaccine，30 days after the second dose of trial vaccine.

• Seroprotection Rate (SPR)

  Seroprotection Rate (SPR) of HI antibodies of 4 vaccine types in all subjects

  28 days after the first dose of trial vaccine, 30 days after the second dose of trial vaccine.

• Geometric Mean Titer

  Geometric Mean Titer of HI antibodies of 4 vaccine types in all subjects

  28 days after the first dose of trial vaccine，30 days after the second dose of trial vaccine.

• Incidence of adverse reactions

  Incidence of adverse reactions within 0-28 (after the first dose) /0-30 (after the second dose) days after inoculation

  Incidence of adverse reactions within 0-28 (after the first dose) /0-30 (after the second dose) days after inoculation

• Incidence of all adverse events

  • Incidence of all adverse events 30 minutes after each dose;Incidence of all adverse events 7 days after each dose;

  • Incidence of all adverse events 30 minutes after each dose;Incidence of all adverse events 7 days after each dose;

• Incidence of all serious adverse events

  Incidence of all serious adverse events from the first dose to 6 months after full vaccination;

  Incidence of all serious adverse events from the first dose to 6 months after full vaccination;

• Incidence of AE/SAE leading to withdrawal.

  Incidence of AE/SAE leading to withdrawal.

  Incidence of AE/SAE leading to withdrawal within seven month during the study period

Study Arms (3)

Trial group 1 (No previous influenza vaccination)

OTHER

Subjects with no previous influenza vaccination

Biological: Inavtivated Quadrivalent Influenza Virus Split Vaccine

Trial group 2 (previous vaccinated with one dose of influenza vaccine)

OTHER

Subjects previously vaccinated with one dose of influenza vaccine

Biological: Inavtivated Quadrivalent Influenza Virus Split Vaccine

Trial group 2 (previous vaccinated with two doses of influenza vaccine)

OTHER

Subjects previously vaccinated with two dose of influenza vaccine

Biological: Inavtivated Quadrivalent Influenza Virus Split Vaccine

Interventions

Inavtivated Quadrivalent Influenza Virus Split Vaccine BIOLOGICAL

Prevent influenza caused by H1N1, H3N2, B (V), B (Y) strain virus infection.

Trial group 1 (No previous influenza vaccination); Trial group 2 (previous vaccinated with one dose of influenza vaccine); Trial group 2 (previous vaccinated with two doses of influenza vaccine)

Eligibility Criteria

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

You may qualify if:

• At the age of 3 years old and below 9 years old on the day of enrollment, valid identification of the subject and/or his/her guardian can be provided;
• The subject's guardian has the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent (8-year-old subject: The subject and his/her guardian voluntarily agree to participate in the study, and the informed consent shall be signed by his/her guardian and the subject shall sign the informed consent for minors; Subjects aged 3-7: The guardian of the subject voluntarily agrees that the child should participate in the study, and the guardian should sign the informed consent);
• The subject's guardian is competent to understand the study procedures, and the subject and/or his/her guardian are able to attend all planned follow-up visits;
• Axillary temperature on the day of enrollment \< 37.5℃.

You may not qualify if:

• Have a history of severe allergy to any components of the test vaccine (including eggs and ovalbumin, etc.), such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthus reaction);
• patients with influenza or influenza-like symptoms within 3 months (fever \< axillary temperature ≥38℃ \>, accompanied by cough or sore throat);
• Patients with acute diseases or acute episodes of chronic diseases within 3 days before vaccination;
• Before enrollment, the interval between other inactivated vaccines was less than 7 days, and the interval between live attenuated vaccines was less than 14 days;
• Fever or antipyretic analgesics and antiallergic drugs were used in the first 3 days before enrollment;
• Long-term use of immunosuppressants or other immunomodulatory drugs within 3 months prior to enrollment (defined as continuous use for more than 14 days), such as glucocorticoid dose ≥0.5mg/kg/ day (inhalation and local glucocorticoid are not restricted);
• Received blood or blood related products 6 months before enrollment;
• have been diagnosed with congenital or acquired immunodeficiency;
• done with may interfere with study or severe disease or congenital malformations (including but not limited to, the researchers determine unfavorable into groups: respiratory diseases such as asthma or chronic bronchitis attack, down syndrome, during the Mediterranean anemia, heart disease, kidney disease, autoimmune diseases, genetic allergic constitution, GBS, skin diseases, etc.);
• History or family history of convulsions, epilepsy, encephalopathy and mental illness;
• There are contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment;
• absence of spleen, functional absence of spleen, and absence of spleen or splenectomy resulting from any circumstance;
• Plan to move out of the local area before the end of the study or leave the area for an extended period during the scheduled study visit;
• The investigator considers that the subject has any conditions that might interfere with the evaluation of the study purpose.
• The second dose delayed the standard of inoculation If any of the following occurs, the researchers will delay vaccination until the situation abates.

Sponsors & Collaborators

• Wuhan Institute of Biological Products Co., Ltd: lead

Study Sites (1)

Yangchun Center for Disease Control and Prevention

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Jikai Zhang

  Guangdong province institute of biologicals and materia medica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 25, 2022
• Study Start: March 2, 2022
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)