A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years

NCT ID: NCT05144464

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-19
• Study Completion Date: 2022-04-30

Brief Summary

Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For those aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. For those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine, they require 2 dose of influenza vaccine. but the evidence on how to select vaccine doses for quadrivalent influenza vaccine is limited in China. The study is a prospective, open-label comparison of the immunogenicity and reactogenicity of 1 versus 2 doses of an inactivated quadrivalent influenza vaccine in subjects of 3-8 years old with different history of influenza vaccination.

Detailed Description

Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.

Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2, A/H1N1, and B antigens included in the vaccine were measured at each time point

Conditions

Influenza

Study Design

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

Study Groups

Quadrivalent influenza vaccine

Subjects received 2 doses of 0.5 mL of quadrivalent influenza vaccine, 4 weeks apart. Each 0.5-ml dose contained 15 μg of hemagglutinin per strain.

Group Type: EXPERIMENTAL

Quadrivalent influenza vaccine

Intervention Type: BIOLOGICAL

Subjects receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection

Interventions

Quadrivalent influenza vaccine

Subjects receive two doses of quadrivalent influenza vaccine administered 4 weeks apart by intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Aged 3-8 years old
• Healthy subjects judged from medical history and clinical examination
• Subjects themselves or their guardians able to understand and sign the informed consent
• Subjects themselves or their guardians can and will comply with the requirements of the protocol
• Subjects have received ≥2 doses of trivalent or quadrivalent infuenza vaccine before enrollment (Doses need not have been received during same or consecutive seasons); Subjects have not received infuenza vaccine before enrollment
• Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria

• Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
• Subject who is allergic to any ingredient of the vaccine
• Subject with damaged or low immune function which has already been known
• Subject with acute febrile illness or infectious disease
• Major congenital defects or serious chronic illness, including perinatal brain damage
• Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
• Subject who has serious allergic history
• Subject who developed guillain-Barre syndrome post influenza vaccination
• Any prior administration of immunodepressant or corticosteroids in last 6 months
• Any prior administration of influenza vaccine in last 6 month
• Any prior administration of blood products in last 3 months
• Any prior administration of other research medicine/vaccine in last 30 days
• Any prior administration of any attenuated live vaccine in last 14 days
• Any prior administration of subunit or inactivated vaccines in last 7 days, such as pneumococcal vaccine
• Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent for subject's guardian

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

Sponsors

Jiangsu Jindike Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fangyue Meng, Master

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Province Centers for Disease Control and Prevention

Locations

Pizhou City Center for Disease Control and Prevention

Xuzhou, Jiangsu, China

Countries

China

References

Wen F, Liu S, Zhou L, Zhu Y, Wang W, Wei M, Xu X, Liu Y, Shuai Q, Yu J, Jing P, Li J, Zhu F. Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3-8 years with or without previous influenza vaccination histories. Hum Vaccin Immunother. 2025 Dec;21(1):2468074. doi: 10.1080/21645515.2025.2468074. Epub 2025 Feb 24.

Reference Type: DERIVED

PMID: 39993940 (View on PubMed)

Other Identifiers

JSVCT122

Identifier Type: -

Identifier Source: org_study_id