Not Yet RecruitingPhase 1

Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine

China60 participantsStarted 2026-03-09

Plain-language summary

To evaluate the safety of Sinovac RSV mRNA among participants aged ≥18 years

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participants can understand and voluntarily sign the informed consent form;
✓. Able to provide legal identity documents;
✓. Healthy individuals aged 18 years and above;
✓. Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures (such as correct use of condoms, or female participants using combined oral contraceptives, intrauterine devices) from the time the participant signs the informed consent form until 6 months after the administration of the investigational vaccine, and have no plans to donate sperm or ovums; Female participants of childbearing potential must also have adopted effective contraceptive measures within 2 weeks before enrollment.

Exclusion criteria

✕. Those with fever on the day of vaccination with the trial vaccine, with an axillary temperature \> 37.0℃ before vaccination;
✕. Those with a history of previous RSV vaccination, or a history of RSV infection within 6 months before enrollment.
✕. Known to be allergic to vaccines or vaccine components;
✕. Before vaccination, the electrocardiogram examination and clinical laboratory test indicators specified in the protocol are abnormal and clinically significant;
✕. Female participants who are breastfeeding or pregnant;
✕. Having autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, splenectomy, HIV infection);
✕. History of poorly controlled chronic diseases or severe diseases, including but not limited to cardiovascular diseases (such as hypertension uncontrolled by drugs, i.e., systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg for participants aged 18-59 years old, systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg for participants aged 60 years old and above, as well as congenital heart disease, atrial fibrillation, myocarditis, pericarditis), hematological system diseases, liver and kidney diseases, respiratory system diseases, malignant tumors, history of transplantation of major functional organs, or any other diseases or physiological conditions that the researcher believes can interfere with the trial results;
✕. Current encephalopathy (such as damage to cerebral nerve tissue caused by congenital hypoplasia of the brain, brain trauma, brain tumors, cerebral hemorrhage, brain infection, chemical drug poisoning, etc.);

What they're measuring

Incidence of adverse events

Timeframe: Up to 30 days after vaccination

Trial details

NCT IDNCT07418229

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Weimin Zhao, Dr.

+86 13934135335 283282678@qq.com

View on ClinicalTrials.gov More RSV trials