A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine
NCT ID: NCT06754605
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
480 participants
INTERVENTIONAL
2025-02-06
2027-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults
NCT05148091
Safety and Immunogenicity of the Recombinant Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 18 Years and Older
NCT06904222
A Phase 2 Study to Describe the Safety and Immunogenicity of Respiratory Syncytial Virus Vaccine IN006 in Healthy Participants Aged 60 Years and Older
NCT07128121
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
NCT07208461
A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adult Aged 18 Years and Above
NCT06645665
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A: Low dose vaccine
Low dose of SCTV02, injected on Day 0
SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
A: Low dose placebo
Placebo comparator of low dose, injected on Day 0
Placebo
Participants will receive a singe dose of Placebo on Day 0.
B: Medium dose vaccine
Medium dose of SCTV02, injected on Day 0
SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
B: Medium dose placebo
Placebo comparator of medium dose, injected on Day 0
Placebo
Participants will receive a singe dose of Placebo on Day 0.
C: High dose vaccine
High dose of SCTV02, injected on Day 0
SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
C: High dose placebo
Placebo comparator of high dose, injected on Day 0
Placebo
Participants will receive a singe dose of Placebo on Day 0.
D: Low dose vaccine
Low dose of SCTV02, injected on Day 0
SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
E: Medium dose vaccine
Medium dose of SCTV02, injected on Day 0
SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
F: High dose vaccine
High dose of SCTV02, injected on Day 0
SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
G: Placebo
Placebo comparator, injected on Day 0
Placebo
Participants will receive a singe dose of Placebo on Day 0.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
Placebo
Participants will receive a singe dose of Placebo on Day 0.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Be able to sign a written Informed consent form (ICF) and participate in the trial voluntarily, and can fully understand the trial procedures and risks of participating in the trial.
* Be able to complete the diary card, contact card and diary/contact card by own or with the assistance of others.
* Phase I: healthy subjects or healthy subjects judged by the investigator according to the clinical data of the subjects; Stage II: Subjects who are healthy or have a stable underlying disease.
* Fertile men and women of childbearing age voluntarily agree to use effective contraception from the time they sign the ICF until 6 months after immunization; Pregnancy test results for women of childbearing age during the screening period were negative.
Exclusion Criteria
* Use any investigational or unregistered product within 30 days prior to immunization, or plan to use any such product during the study period.
* Concurrent participation in another clinical study where the subject has been or will be exposed to an investigational or non-investigational vaccine/product at any time during the study.
* Long-term or high-dose glucocorticoid therapy (duration ≥15 days, or dose ≥1 mg/kg/ day of prednisone or equivalent doses of other glucocorticoids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination.
* The study received a non-attenuated vaccine within 14 days prior to vaccination, or a live attenuated vaccine within 28 days; Have previously received the experimental respiratory syncytial virus (RSV) vaccine or been infected with RSV within 1 year prior to receiving the investigational vaccine.
* History or family history of epilepsy and mental illness.
* A family history of congenital or hereditary immunodeficiency, or a history and physical examination confirmed or suspected immunosuppression or immunodeficiency, or human immunodeficiency virus (HIV) infection, asplenia or functional asplenia.
* Have the following organ-specific or systemic autoimmune diseases: Guillain-Barre syndrome, myasthenia gravis, autoimmune hepatitis, ulcerative colitis, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, and systemic sclerosis.
* Allergic to any component of the study vaccine, or any previous history of severe allergy to vaccine vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.
* Severe chronic disease or active chronic disease, as assessed by the investigator, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, uncontrolled blood pressure after medication (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg in subjects \< 60 years of age; Hypertensive disease with systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg in subjects ≥60 years of age, diabetes mellitus with serious complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart diseases, respiratory diseases, liver and kidney diseases, and thyroid diseases.
* Pregnant women (positive pregnancy test) or breastfeeding women, or those with pregnancy plans during the study period, or less than 6 weeks after the end of pregnancy (including ectopic pregnancy).
Plan to donate eggs or sperm during the study.
* Unable to follow the trial procedures, or plan to relocate or stay away for a long period of time during the study and cannot complete the trial follow-up.
* Any medical condition that makes intramuscular injection unsafe due to other abnormalities, conditions that may obfuscate the results of the study, or conditions that are not in the best interest of the subject, is determined by the investigator to be unsuitable for clinical study.
18 Years
120 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sinocelltech Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhao Kexin, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hebei Zhongshiyou Central Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hebei Zhongshiyou Central Hospital
Langfang, Hebei, China
Luzhou Center for Disease Control and Prevention
Luzhou, Sichuan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zhao Kexin, Doctor
Role: primary
He Wenlin, Doctor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SCTV02-X201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.