A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years

Launched by SHANGHAI INSTITUTE OF BIOLOGICAL PRODUCTS · Aug 27, 2019

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy volunteers aged over 40 years (male or female).
• • Able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period.
• • Able to understand the content of informed consent and willing to sign the informed consent.
• • Able to complete the diary card independently.
• • Patients with chronic diseases need to be in a stable period.
• • Axillary temperature ≤37.0°C.
• Exclusion Criteria:
• • Prior history of herpes zoster.
• • Prior history of vaccination with herpes zoster vaccine or chickenpox vaccine.
• • History of allergic disease likely to be exacerbated by any component of the vaccine.
• • Taking immunoglobulins and/or any blood products within the last 3 months or will receive these products during the study period.
• • Taking certain pharmaceuticals to be like salicylate kind, including aspirin, and difluorosalicylic, or going to take these medicine during the study period.
• • Participation in another research study involving receipt of an investigational product in the last 30 days.
• • Prior administration of live vaccine in last 30 days.
• • Prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days.
• • History of serious disease and the participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index.
• • Taking immunosuppressive therapy in last 6 months.
• • Any autoimmune disease or immunodeficient state, autoimmune disease or immunodeficient disease.
• • Active tuberculosis patient.
• • Acute or chronic infections at the vaccination day (axillary temperature≥ 38.0°C).
• • Coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed.
• • Woman who is breast-feeding.
• • Previous history of mental and neurological diseases (e.g. depression, epilepsy or convulsion)
• • Planned to move before the end of the study or leave the country for a long time during the scheduled study visit.
• • Abnormal Blood Routine and Biochemical Indexes before Inoculation (except for minor abnormalities that are not clinically significant as judged by doctors)
• • Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.