This phase 1 study in China will evaluate the Safety and Preliminary Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Adults Aged 18 Years and Older
Adults aged 18 years and older who reside in the local area and can provide legal proof of identity; sex is not restricted;
Trial participants understand the informed consent form and the vaccine to be administered, voluntarily agree to participate and sign the informed consent form, and are able to use a thermometer and ruler and complete the diary card and contact card as required. If a participant is unable to sign the informed consent form independently because of limited literacy, the informed consent process and signature may be completed with the assistance of an impartial witness;
Able to communicate effectively with the investigator and understand and comply with all trial requirements;
Women of childbearing potential (see Appendix 2 for the definition) must have used effective contraception for 2 weeks before enrollment, have a negative urine pregnancy test before investigational vaccine administration (women not of childbearing potential are exempt), and voluntarily agree to continue using at least one effective contraceptive method for 6 months after vaccination. Effective contraception includes oral contraceptives, injectable or implantable contraception, long-acting local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, male condoms, diaphragms, cervical caps, etc. Male trial participants must agree to use effective contraception with female partners of reproductive potential from the screening visit until 6 months after immunization.
Abnormal pre-vaccination laboratory tests (complete blood count, blood biochemistry, coagulation function, C-reactive protein, or urinalysis) or 12-lead electrocardiogram findings that, based on medical history and clinical presentation, render the person unsuitable for vaccination in the investigator's judgment;
Abnormal skin at the vaccination sites on both arms at the vaccination visit (e.g., inflammation, induration, erythema/swelling, or extensive scars);
Hypertension not controlled by medication, or pre-enrollment systolic blood pressure of at least 160 mmHg and/or diastolic blood pressure of at least 100 mmHg;
Axillary temperature of at least 37.1 degrees C on the day of vaccination; fever, acute illness, or an acute exacerbation of chronic disease within the preceding 3 days; or use of antipyretic/analgesic or anti-allergy medications within the preceding 3 days;
Parallel
Recombinant RSV Vaccine (CHO Cell)
Biological/Vaccine0.4 mL per dose
Recombinant RSV Vaccine (CHO Cell)
Biological/Vaccine0.8 mL per dose
Adjuvant Suspension
Biological/Vaccine0.9 mL per dose
Recombinant RSV Vaccine (CHO Cell) with Adjuvant Suspension
Biological/Vaccine0.9 mL per dose
Saline solution
Biological/Vaccine0.9 mL per dose
10
Treatment groupsSee each treatment group below.
Incidence of immediate adverse events
Incidence of all adverse events within 30 minutes after vaccination
Incidence of solicited AEs
Incidence of solicited (local and systemic) adverse events within 14 days after vaccination
Incidence of unsolicited AEs
Incidence of unsolicited adverse events within 30 days after vaccination
Incidence of clinically significant abnormalities in clinical laboratory tests
Incidence of clinically significant abnormal laboratory test results on Day 4 after vaccination
Incidence of clinically significant abnormal findings on 12-lead electrocardiograms
Incidence of clinically significant abnormal findings on 12-lead electrocardiograms on Days 4, 14, and 30 after vaccination
Occurrence of serious adverse events (SAEs)
Occurrence of serious adverse events (SAEs) within 24 months after vaccination
Occurrence of adverse events of special interest (AESIs)
Occurrence of adverse events of special interest (AESIs) within 12 months after vaccination
Click on the lead sponsor to view all of their trials.
Yikang Biotech (Suzhou) Co., Ltd.
Lead sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
