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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Low-dose RSV mRNA vaccine
Biological/VaccineOne dose of RSV mRNA vaccine in low dosage
High-dose RSV mRNA vaccine
Biological/VaccineOne dose of RSV mRNA vaccine in high dosage
Placebo
Other interventionParticipants will receive one dose of normal saline.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Sinovac RSV mRNA vaccine low-dose groupExperimental treatment 1 intervention
Group B: Sinovac RSV mRNA vaccine high-dose groupExperimental treatment 1 intervention
Group C: Placebo control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events
Time frame
Up to 30 days after vaccinationSecondary outcomes
1
Incidence of adverse events
Time frame
Up to 14 days after vaccination2
Incidence of serious adverse events and adverse events of special interest
Time frame
Up to 12 months after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: