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

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: Quadrivalent influenza vaccine

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT05313893

SJLGYM-2021-Ⅳ-01

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 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent 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 receiptof dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each timepoint

Enrollment

252 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 theinformed consent
Subjects themselves or their guardians can and will comply with therequirements of the protocol
Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment
Subjects with temperature <=37.0°C on axillary setting

Exclusion criteria

Any prior administration of other research medicine/vaccine in last 30 days
Any prior administration of influenza vaccine in last 6 month
Any prior administration of immunodepressant or corticosteroids in last 3 months
Any prior administration of blood products in last 3 months
Any prior administration of any attenuated live vaccine in last 14 days
Any prior administration of subunit or inactivated vaccines in last 7 days
Subject who developed guillain-Barre syndrome post influenza vaccination
Subject who is allergic to any ingredient of the vaccine
Subject with acute febrile illness or infectious disease
Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection
Subject with damaged or low immune function which has already beenknown
Subject with congenital heart disease or other birth defects unsuitable for vaccination.
Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections.
Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol