Safety and Immunogenicity Study of SCB-1019T in Children
- Conditions
- RSV Infection
- Interventions
- Biological: low dose SCB-1019TBiological: adjuvanted low dose SCB-1019TOther: PlaceboBiological: high dose SCB-1019TBiological: adjuvanted high dose SCB-1019T
- Registration Number
- NCT06666179
- Lead Sponsor
- Clover Biopharmaceuticals AUS Pty Ltd
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 112
• 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 (low dose SCB-1019T ) low dose SCB-1019T 24 children (2-\<6 years of age) will receive low-dose unadjuvanted SCB-1019T at Day 1 Group 2 (adjuvanted low dose SCB-1019T) adjuvanted low dose SCB-1019T 24 children (2-\<6 years of age) will receive low-dose adjuvanted SCB-1019T at Day 1 Group 3 (Placebo) Placebo 8 children (2-\<6 years of age) will receive placebo at Day 1 Group 4 (high dose SCB-1019T) high dose SCB-1019T 24 children (2-\<6 years of age) will receive high-dose unadjuvanted SCB-1019T at Day 1 Group 5 ( adjuvanted high dose SCB-1019T) adjuvanted high dose SCB-1019T 24 children (2-\<6 years of age) will receive high-dose adjuvanted SCB-1019T at Day 1 Group 6 (Placebo) Placebo 8 children (2-\<6 years of age) will receive placebo at Day 1
- Primary Outcome Measures
Name Time Method Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine Within 7 days after vaccination Porportion of participants with local and systemic solicied AEs
Evaluate porportions of participants with unsolicited AEs of SCB-1019T vaccine Within 28 days after vaccination Porportions of participants with unsolicited AEs
Evaluate porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019T vaccine Throughout the study period, from enrollment to 6 months follow up Porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Kids Research Institute
🇦🇺Perth, Western Australia, Australia