NCT06342349

A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.

A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above.

Detailed description

This is a single center, randomized, double-blind, controlled phase I clinical trial. Plan to include 300 participants aged 6 months and above. The experiment was divided into 5 age groups, with 60 cases each aged 6-35 months, 3-8 years, 9-17 years, 18-59 years, and ≥ 60 years old. Each age group was randomly assigned to the experimental group, control group, or placebo group in a 1:1:1 ratio. Among them, the participants aged 6 to 35 months and 3 to 8 years old will receive 2 doses throughout the entire process, with an interval of 28 days between each dose. Participants aged 9-17, 18-59, and ≥ 60 years old are vaccinated with one dose throughout the entire process.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent influenza virus split vaccine (MDCK cells)	Quadrivalent influenza vaccine made from cell matrix (0.5ml/dose).
BIOLOGICAL	Quadrivalent influenza virus split vaccine (Chicken embryo)	Quadrivalent influenza vaccine made from chicken embryo(0.5ml/dose).
OTHER	Phosphate buffer solution	Phosphate buffer solution without vaccine antigen(0.5ml/dose).

Timeline

• Start date: 2024-03-30
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-04-02
• Last updated: 2025-02-19

Locations

1 site across 1 country: China