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

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase

Unknown

Phase 4

Conditions

Influenza

Treatments

Biological: Quadrivalent influenza vaccine

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT05144464

JSVCT122

Details and patient eligibility

About

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.

Full 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

Enrollment

240 estimated patients

Sex

All

Ages

3 to 8 years old

Volunteers

Accepts Healthy Volunteers

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