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Safety and Immunogenicity Study of SCB-1019T in Children

NCT ID: NCT06666179

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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RSV Infection

Keywords

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RSV vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1 (low dose SCB-1019T )

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

Group Type EXPERIMENTAL

low dose SCB-1019T

Intervention Type BIOLOGICAL

Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Group 2 (adjuvanted low dose SCB-1019T)

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

Group Type EXPERIMENTAL

adjuvanted low dose SCB-1019T

Intervention Type BIOLOGICAL

Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Group 3 (Placebo)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

0.9% NaCl saline placebo

Group 4 (high dose SCB-1019T)

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

Group Type EXPERIMENTAL

high dose SCB-1019T

Intervention Type BIOLOGICAL

Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Group 5 ( adjuvanted high dose SCB-1019T)

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

Group Type EXPERIMENTAL

adjuvanted high dose SCB-1019T

Intervention Type BIOLOGICAL

Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Group 6 (Placebo)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

0.9% NaCl saline placebo

Interventions

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low dose SCB-1019T

Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Intervention Type BIOLOGICAL

adjuvanted low dose SCB-1019T

Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Intervention Type BIOLOGICAL

high dose SCB-1019T

Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Intervention Type BIOLOGICAL

adjuvanted high dose SCB-1019T

Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)

Intervention Type BIOLOGICAL

Placebo

0.9% NaCl saline placebo

Intervention Type OTHER

Eligibility Criteria

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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.

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.
Minimum Eligible Age

24 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clover Biopharmaceuticals AUS Pty

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Kids Research Institute

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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CLO-SCB-1019-003

Identifier Type: -

Identifier Source: org_study_id