Study Stopped
The study was terminated during the EC submission process prior to the enrolment
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
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2024
CompletedFirst Posted
Study publicly available on registry
October 30, 2024
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
December 31, 2024
December 1, 2024
8 months
October 29, 2024
December 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine
Porportion of participants with local and systemic solicied AEs
Within 7 days after vaccination
Evaluate porportions of participants with unsolicited AEs of SCB-1019T vaccine
Porportions of participants with unsolicited AEs
Within 28 days after vaccination
Evaluate porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019T vaccine
Porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Throughout the study period, from enrollment to 6 months follow up
Study Arms (6)
Group 1 (low dose SCB-1019T )
EXPERIMENTAL24 children (2-\<6 years of age) will receive low-dose unadjuvanted SCB-1019T at Day 1
Group 2 (adjuvanted low dose SCB-1019T)
EXPERIMENTAL24 children (2-\<6 years of age) will receive low-dose adjuvanted SCB-1019T at Day 1
Group 3 (Placebo)
PLACEBO COMPARATOR8 children (2-\<6 years of age) will receive placebo at Day 1
Group 4 (high dose SCB-1019T)
EXPERIMENTAL24 children (2-\<6 years of age) will receive high-dose unadjuvanted SCB-1019T at Day 1
Group 5 ( adjuvanted high dose SCB-1019T)
EXPERIMENTAL24 children (2-\<6 years of age) will receive high-dose adjuvanted SCB-1019T at Day 1
Group 6 (Placebo)
PLACEBO COMPARATOR8 children (2-\<6 years of age) will receive placebo at Day 1
Interventions
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
Eligibility Criteria
You may qualify if:
- Male and female participants 2 to \<6 years of age at Visit 1. • Parents/guardians of participants willing and able to provide written informed consent and comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. • Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator.
You may not qualify if:
- Acute disease or fever (≥38°C) at time of vaccination. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled.
- Evidence of chronic diseases including hepatitis, bleeding disorders, metabolic diseases, autoimmune diseases, neurological conditions that impair respiratory functions, genetic disorders that increase the risk of severe respiratory diseases, major congenital malformations, cardiac and lung diseases or reactive airway diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Kids Research Institute
Perth, Western Australia, 6009, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2024
First Posted
October 30, 2024
Study Start
October 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 31, 2024
Record last verified: 2024-12