NCT05313893

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

A Clinical Trial to Assess Immunogencity and Safety of 2 Doses of anInactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8Years

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent influenza vaccine	Subjects receive two doses of quadrivalent influenzavaccine administered 4 weeks apart by intramuscularinjection. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain.

Timeline

• Start date: 2021-09-11
• Primary completion: 2021-12-25
• Completion: 2022-05-30
• First posted: 2022-04-06
• Last updated: 2022-08-17

Locations

1 site across 1 country: China