NCT05642078

Phase Ⅲ Clinical Study of Quadrivalent Influenza Virus Split Vaccine

A Randomized, Blind, Position-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Quadrivalent Influenza Virus Split Vaccine in 6-35 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,550 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.

Detailed description

A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety. Immunogenicity observation Venous blood (2.5-3.0ml) was collected from all subjects before the first dose and 30 days after the full dose, and serum was separated for detection of Hemagglutination Inhibition antibodies against four influenza virus serotypes (H1N1, H3N2, B (V), B (Y)). Safety observation All AE within 30 minutes of each dose, solicited adverse events at 0-7 days, non-solicited adverse events at 0-28 days (first dose) /30 days (second dose), and all serious adverse events from the first dose to 6 months after the full dose were collected.

Conditions

• Prevention of Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Investigational Vaccine(0.25ml/vial)	Subjects were vaccinated with a dose of low-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.
BIOLOGICAL	Investigational Vaccine(0.5ml/vial)	Subjects were vaccinated with a dose of high-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.
BIOLOGICAL	Active compared Vaccine	Subjects were vaccinated with a dose of active compared vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.

Timeline

• Start date: 2023-02-18
• Primary completion: 2024-01-05
• Completion: 2024-01-05
• First posted: 2022-12-08
• Last updated: 2024-01-10

Locations

1 site across 1 country: China