RSV InfectionPhase 1NCT06666179
Safety and Immunogenicity Study of SCB-1019T in Children
A Phase 1 study testing low dose SCB-1019T, adjuvanted low dose SCB-1019T and high dose SCB-1019T in people with RSV Infection, run by Clover Biopharmaceuticals AUS Pty at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- RSV Infection
- What is being tested?
- low dose SCB-1019T, adjuvanted low dose SCB-1019T and high dose SCB-1019T
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- RSV Infection
- Being tested
- low dose SCB-1019T, adjuvanted low dose SCB-1019T, high dose SCB-1019T, adjuvanted high dose SCB-1019T, Placebo
- Keywords
- RSV vaccine
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose SCB-1019TBiological
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
adjuvanted low dose SCB-1019TBiological
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
high dose SCB-1019TBiological
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
adjuvanted high dose SCB-1019TBiological
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
PlaceboOther
0.9% NaCl saline placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (low dose SCB-1019T ) | Experimental | 24 children (2-<6 years of age) will receive low-dose unadjuvanted SCB-1019T at Day 1 Receives: Biological: low dose SCB-1019T |
| Group 2 (adjuvanted low dose SCB-1019T) | Experimental | 24 children (2-<6 years of age) will receive low-dose adjuvanted SCB-1019T at Day 1 Receives: Biological: adjuvanted low dose SCB-1019T |
| Group 3 (Placebo) | Placebo comparator | 8 children (2-<6 years of age) will receive placebo at Day 1 Receives: Other: Placebo |
| Group 4 (high dose SCB-1019T) | Experimental | 24 children (2-<6 years of age) will receive high-dose unadjuvanted SCB-1019T at Day 1 Receives: Biological: high dose SCB-1019T |
| Group 5 ( adjuvanted high dose SCB-1019T) | Experimental | 24 children (2-<6 years of age) will receive high-dose adjuvanted SCB-1019T at Day 1 Receives: Biological: adjuvanted high dose SCB-1019T |
| Group 6 (Placebo) | Placebo comparator | 8 children (2-<6 years of age) will receive placebo at Day 1 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine
Porportion of participants with local and systemic solicied AEs
Measured: Within 7 days after vaccination
Evaluate porportions of participants with unsolicited AEs of SCB-1019T vaccine
Porportions of participants with unsolicited AEs
Measured: Within 28 days after vaccination
Evaluate porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019T vaccine
Porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Measured: Throughout the study period, from enrollment to 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study startOct 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: The study was terminated during the EC submission process prior to the enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clover Biopharmaceuticals AUS Pty
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666179
- Sponsor's protocol ID
- CLO-SCB-1019-003
- Status last verified
- Dec 2024
- First submitted
- 29 Oct 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06666179
- Acronym / sponsor ID
- CLO-SCB-1019-003
- Conditions
- RSV Infection
- Keywords
- RSV vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated during the EC submission process prior to the enrolment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clover Biopharmaceuticals AUS PtyIndustry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 (low dose SCB-1019T ) | Experimental | Biological: low dose SCB-1019T24 children (2-<6 years of age) will receive low-dose unadjuvanted SCB-1019T at Day 1 |
| Group 2 (adjuvanted low dose SCB-1019T) | Experimental | Biological: adjuvanted low dose SCB-1019T24 children (2-<6 years of age) will receive low-dose adjuvanted SCB-1019T at Day 1 |
| Group 3 (Placebo) | Placebo comparator | Other: Placebo8 children (2-<6 years of age) will receive placebo at Day 1 |
| Group 4 (high dose SCB-1019T) | Experimental | Biological: high dose SCB-1019T24 children (2-<6 years of age) will receive high-dose unadjuvanted SCB-1019T at Day 1 |
| Group 5 ( adjuvanted high dose SCB-1019T) | Experimental | Biological: adjuvanted high dose SCB-1019T24 children (2-<6 years of age) will receive high-dose adjuvanted SCB-1019T at Day 1 |
| Group 6 (Placebo) | Placebo comparator | Other: Placebo8 children (2-<6 years of age) will receive placebo at Day 1 |
Who may qualify
- Ages
- 24 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose SCB-1019TBivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) | Biological | Group 1 (low dose SCB-1019T ) |
| adjuvanted low dose SCB-1019TBivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) | Biological | Group 2 (adjuvanted low dose SCB-1019T) |
| high dose SCB-1019TBivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) | Biological | Group 4 (high dose SCB-1019T) |
| adjuvanted high dose SCB-1019TBivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) | Biological | Group 5 ( adjuvanted high dose SCB-1019T) |
| Placebo0.9% NaCl saline placebo | Other | Group 3 (Placebo), Group 6 (Placebo) |
Primary outcome
Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing low dose SCB-1019T, adjuvanted low dose SCB-1019T and high dose SCB-1019T in people with RSV Infection, run by Clover Biopharmaceuticals AUS Pty at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine (time frame: Within 7 days after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.