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

NCT ID: NCT05138705

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-14
• Study Completion Date: 2022-08-05

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.

Detailed Description

To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures, and the participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at day 0 and 28.

Conditions

Influenza, Human

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Outcome

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

Group Type: EXPERIMENTAL

Quadrivalent Influenza Virus Split Vaccine

Intervention Type: 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

Interventions

Quadrivalent Influenza Virus Split Vaccine

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Other reasons for exclusion considered by the investigator.

Exclusion Criteria

• 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;
• Participating in or planning to participate in other clinical trials in the near future;
• Any conditions judged by investigators that were inappropriate for participation in this clinical trial.

Receiving the second dose of vaccine

• Have a severe allergic reaction after receiving the first dose of vaccine;
• Serious adverse events occurred that were causally related to the first dose of vaccine injection；

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Institute Of Biological Products

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Zhang

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Center for Disease Control and Prevention

Locations

Tingting and Yu

Tai’an, Shandong, China

Countries

China

Other Identifiers

2021S00207-01

Identifier Type: -

Identifier Source: org_study_id