Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinovac Biotech Co., Ltd
About this trial
To evaluate the safety of Sinovac RSV mRNA among participants aged ≥18 years
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Low-dose RSV mRNA vaccine
- High-dose RSV mRNA vaccine
- Placebo
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov