NCT05138705

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

An Open Phase IV Clinical Trial of Quadrivalent Influenza Virus Split Vaccine to Evaluate the Safety and Immunogenicity in Healthy Population Aged 3-8 Years

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	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

Timeline

• Start date: 2021-12-14
• Primary completion: 2022-02-28
• Completion: 2022-08-05
• First posted: 2021-12-01
• Last updated: 2023-08-14

Locations

1 site across 1 country: China