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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06666179




Registration number
NCT06666179
Ethics application status
Date submitted
29/10/2024
Date registered
30/10/2024

Titles & IDs
Public title
Safety and Immunogenicity Study of SCB-1019T in Children
Scientific title
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
Secondary ID [1] 0 0
CLO-SCB-1019-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
RSV Infection 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - low dose SCB-1019T
Treatment: Other - adjuvanted low dose SCB-1019T
Treatment: Other - high dose SCB-1019T
Treatment: Other - adjuvanted high dose SCB-1019T
Other interventions - Placebo

Experimental: Group 1 (low dose SCB-1019T ) - 24 children (2-\<6 years of age) will receive low-dose unadjuvanted SCB-1019T at Day 1

Experimental: Group 2 (adjuvanted low dose SCB-1019T) - 24 children (2-\<6 years of age) will receive low-dose adjuvanted SCB-1019T at Day 1

Placebo comparator: Group 3 (Placebo) - 8 children (2-\<6 years of age) will receive placebo at Day 1

Experimental: Group 4 (high dose SCB-1019T) - 24 children (2-\<6 years of age) will receive high-dose unadjuvanted SCB-1019T at Day 1

Experimental: Group 5 ( adjuvanted high dose SCB-1019T) - 24 children (2-\<6 years of age) will receive high-dose adjuvanted SCB-1019T at Day 1

Placebo comparator: Group 6 (Placebo) - 8 children (2-\<6 years of age) will receive placebo at Day 1


Treatment: Other: low dose SCB-1019T
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Treatment: Other: adjuvanted low dose SCB-1019T
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Treatment: Other: high dose SCB-1019T
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Treatment: Other: adjuvanted high dose SCB-1019T
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Other interventions: Placebo
0.9% NaCl saline placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine
Timepoint [1] 0 0
Within 7 days after vaccination
Primary outcome [2] 0 0
Evaluate porportions of participants with unsolicited AEs of SCB-1019T vaccine
Timepoint [2] 0 0
Within 28 days after vaccination
Primary outcome [3] 0 0
Evaluate porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019T vaccine
Timepoint [3] 0 0
Throughout the study period, from enrollment to 6 months follow up

Eligibility
Key inclusion criteria
• 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.

For full inclusion criteria, please refer to full protocol.
Minimum age
24 Months
Maximum age
71 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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.

For full Exclusion criteria, please refer to full protocol

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
The Kids Research Institute - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Clover Biopharmaceuticals AUS Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xuesong Pei
Address 0 0
Country 0 0
Phone 0 0
+86 185-1544-5890
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06666179