NCT04363359

Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

Immunogenicity and Safety of Quadrivalent Influenza Vaccine In 6 to 35 Months Population: a Randomized, Double-blind, Parallel-group Ⅱ Phase of Clinical Trials

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,980 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

To evaluate the immunogenicity and safety of 2 doses of quadrivalent influenza virus split vaccine in healthy population aged 6-35 month., so as to provide a data support for phase III clinical trials.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	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
BIOLOGICAL	0.25ml Quadrivalent influenza vaccine	The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
BIOLOGICAL	0.25ml Trivalent influenza vaccine(B/V)	The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains
BIOLOGICAL	0.25ml Trivalent influenza vaccine(B/Y)	The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains

Timeline

• Start date: 2020-01-15
• Primary completion: 2021-09-14
• Completion: 2021-09-14
• First posted: 2020-04-27
• Last updated: 2023-12-26

Locations

1 site across 1 country: China