RSV Infection
Conditions
Keywords
RSV vaccine
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.
Interventions
BIOLOGICALlow dose SCB-1019T
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
BIOLOGICALadjuvanted low dose SCB-1019T
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
BIOLOGICALhigh dose SCB-1019T
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
BIOLOGICALadjuvanted high dose SCB-1019T
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
OTHERPlacebo
0.9% NaCl saline placebo
Sponsors
Clover Biopharmaceuticals AUS Pty
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Months to 71 Months
Healthy volunteers
Yes
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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia
Outcome results
None listed