Clinical Trial of Quadrivalent Influenza Virus Split Vaccine in Population Aged 3-8 Years

NCT05138705 | Completed Phase 4

• 1 other identifier: 2021S00207-01
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures.

Conditions

Influenza, Human

Keywords

QIV, safety, immunogenicity

Outcome Measures

Primary Outcomes (4)

• seroconversion rate of hemagglutination inhibition (HI) antibodies

  28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroconversion rate of HI antibodies against any subtype of influenza virus in each group.

  up to 56 days

• seroprotection rate of HI antibodies

  28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroprotection rate of HI antibodies against any subtype of influenza virus in each group.

  up to 56 days

• geometric mean increase (GMI) of HI antibodies

  28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. GMI of HI antibodies against any subtype of influenza virus in each group.

  up to 56 days

• The proportion of all adverse reactions/events

  The proportion of all adverse reactions/events in subjects through 28 days after the second dose.

  up to 56 days

Secondary Outcomes (4)

• p value of difference of seroconversion rate in subjects with different immunization procedures

  up to 56 days

• p value of difference of seroprotection rate in subjects with different immunization procedures

  up to 56 days

• p value of difference of GMI in subjects with different immunization procedures

  up to 56 days

• Reactogenicity Events

  208 days

Study Arms (1)

Outcome

EXPERIMENTAL

Quadrivalent influenza vaccine Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28.

Biological: Quadrivalent Influenza Virus Split Vaccine

Interventions

Quadrivalent Influenza Virus Split Vaccine BIOLOGICAL

0.5ml Quadrivalent influenza vaccine The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/ H3N2, B/Victoria and B/Yamagata strains

Outcome

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. Volunteers are required to show vaccination certificate if they have not received a previous flu vaccine.
• Volunteers' legal guardian or client informed consent, voluntarily participate in and sign informed consent. (Volunteers over the age of 8 also need informed consent and signature)
• Volunteers' legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.

You may not qualify if:

• The axillary temperature greater than 37.0℃ on the day of enrollment;
• Have suffered from influenza within previous 3 months or suffering currently (confirmed by either clinical, serological or microbiological methods);
• Have received any influenza vaccine (registered or experimental) within 6 months or be going to receive other influenza vaccine during the study period;
• Allergic to any component of the vaccine, or have a history of allergic reactions to gentamicin sulfate;
• A history of severe allergy to any vaccine or drug, or with a history of nervous system damage;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
• Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;
• A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;
• Received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);
• Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
• Have a history of asthma, the condition has been unstable for past two years and require treatment, such as emergency treatment, hospitalization, intubation or oral or intravenous administration of corticosteroids and so on;
• Have received blood or blood-related products;
• A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or have a mental illness family history;
• A history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
• Planning to relocate before the end of the study or to leave for an extended period during the scheduled study visit;

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Tingting and Yu

Tai’an, Shandong, 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

• Li Zhang

  Shandong Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects in one group received a first and a second dose of the vaccine at different time points.

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 1, 2021
• Study Start: December 14, 2021
• Primary Completion: February 28, 2022
• Study Completion: August 5, 2022
• Last Updated: August 14, 2023

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)