Actively Recruiting
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine
Led by Sinocelltech Ltd. · Updated on 2025-02-13
480
Participants Needed
2
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomised, double-blind, placebo-controlled Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be male or female aged 18 years or older for Phase I, and 50 years or older for Phase II at the time of consent.
- Must be able to voluntarily sign a written informed consent form and understand trial procedures and risks.
- Must be able to complete diary and contact cards independently or with assistance.
- Phase I participants must be healthy or judged healthy by the investigator; Phase II participants must be healthy or have stable underlying disease.
- Fertile men and women of childbearing age must agree to use effective contraception from consent until 6 months after immunization.
- Women of childbearing age must have a negative pregnancy test during screening.
You will not qualify if you...
- Acute illness or fever (temperature ≥37.3°C) within 3 days before vaccination, or use of antipyretic, analgesic, or antiallergic drugs.
- Use of any investigational or unregistered product within 30 days prior to immunization or planned use during the study.
- Participation in another clinical study involving investigational or non-investigational vaccines/products during this study.
- Long-term or high-dose glucocorticoid therapy or other immunosuppressive/cytotoxic therapy within 90 days prior to vaccination.
- Receipt of non-attenuated vaccine within 14 days or live attenuated vaccine within 28 days prior to vaccination.
- Prior receipt of experimental RSV vaccine or RSV infection within 1 year before vaccination.
- History or family history of epilepsy or mental illness.
- Family history of congenital or hereditary immunodeficiency, confirmed or suspected immunosuppression, HIV infection, asplenia or functional asplenia.
- Presence of specified autoimmune diseases including Guillain-Barre syndrome, myasthenia gravis, autoimmune hepatitis, ulcerative colitis, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, systemic sclerosis.
- Allergy to any component of the study vaccine or severe allergic reactions to vaccines.
- Severe or active chronic diseases such as serious cardiovascular, respiratory, liver, kidney, thyroid diseases, or cancer.
- Pregnant or breastfeeding women, or those planning pregnancy during the study or within 6 weeks after pregnancy.
- Planning to donate eggs or sperm during the study.
- Unable to follow trial procedures or planning to relocate for a long period during the study.
- Any condition making intramuscular injection unsafe or unsuitable for the study as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hebei Zhongshiyou Central Hospital
Langfang, Hebei, China, 965000
Actively Recruiting
2
Luzhou Center for Disease Control and Prevention
Luzhou, Sichuan, China, 646399
Not Yet Recruiting
Research Team
Y
Yang Xinjie, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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