NCT06666179

Safety and Immunogenicity Study of SCB-1019T in Children

A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Reactogenicity and Immunogenicity of a Bivalent Recombinant RSV Vaccine (SCB-1019T) in Children 2 to <6 Years of Age

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Clover Biopharmaceuticals AUS Pty · Industry
• Sex: All
• Age: 24 Months – 71 Months
• Healthy volunteers: Accepted

Summary

This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) in children 2-\<6 years of age.

Detailed description

This Phase 1 randomized, placebo-controlled, observer-blind study will evaluate the safety, reactogenicity and immunogenicity of different formulations of SCB-1019T vaccine in children 2-\<6 years of age. A placebo is used as a control in the study because there is no licensed RSV comparator vaccine available for young children globally.

Conditions

• RSV Infection

Interventions

Type	Name	Description
BIOLOGICAL	low dose SCB-1019T	Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
BIOLOGICAL	adjuvanted low dose SCB-1019T	Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
BIOLOGICAL	high dose SCB-1019T	Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
BIOLOGICAL	adjuvanted high dose SCB-1019T	Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
OTHER	Placebo	0.9% NaCl saline placebo

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-10-30
• Last updated: 2024-12-31

Locations

1 site across 1 country: Australia