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

NCT06101173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-12-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Christina Chang, Dr · Nucleus Network Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2024-03-15
Completion
2024-09-11

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06101173 on ClinicalTrials.gov