NCT06101173

A Study to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults

A Randomized, Observer-Blind, Positive-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults Aged 18-54 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, observer-blind, positive-controlled study. There will be 3 treatment groups, in each treatment group, participants will be randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio that are defined as Dose A, Dose M, and Dose H, respectively) or control vaccine in a ratio of 3:1 in each group. Distribution of participant's gender should be balanced in each group.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio)	1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
BIOLOGICAL	Inactivated poliomyelitis vaccine (IPOL)	1 dose of IPOL vaccine (0.5ml) on Visit 1
BIOLOGICAL	VLP-Polio	1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
BIOLOGICAL	IPOL	1 dose of IPOL vaccine (0.5ml) on Visit 1
BIOLOGICAL	VLP-Polio	1 dose of VLP-Polio vaccine (0.5ml) on Visit 1
BIOLOGICAL	IPOL	1 dose of IPOL vaccine (0.5ml) on Visit 1

Timeline

• Start date: 2024-01-15
• Primary completion: 2024-03-15
• Completion: 2024-09-11
• First posted: 2023-10-26
• Last updated: 2024-12-04

Locations

2 sites across 1 country: Australia