Safety and Immunogenicity Study of SCB-1019T in Children

Clover Biopharmaceuticals

Status and phase: Withdrawn; Phase 1

Conditions: RSV Infection

Treatments: Biological: high dose SCB-1019T; Biological: low dose SCB-1019T; Other: Placebo; Biological: adjuvanted low dose SCB-1019T; Biological: adjuvanted high dose SCB-1019T

Study type: Interventional

Funder types: Other

Identifiers

NCT06666179

CLO-SCB-1019-003

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 24 to 71 months old

Volunteers: Accepts Healthy Volunteers

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 Exclusion criteria, please refer to full protocol

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 6 patient groups, including a placebo group

Group 1 (low dose SCB-1019T )

Experimental group

Description:

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

Treatment:

Biological: low dose SCB-1019T

Group 2 (adjuvanted low dose SCB-1019T)

Experimental group

Description:

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

Treatment:

Biological: adjuvanted low dose SCB-1019T

Group 3 (Placebo)

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Group 4 (high dose SCB-1019T)

Experimental group

Description:

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

Treatment:

Biological: high dose SCB-1019T

Group 5 ( adjuvanted high dose SCB-1019T)

Experimental group

Description:

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

Treatment:

Biological: adjuvanted high dose SCB-1019T

Group 6 (Placebo)

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo