Status:
COMPLETED
A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years
Lead Sponsor:
Shanghai Institute Of Biological Products
Conditions:
Herpes Zoster
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
Brief Summary
Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a loc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT04072497
Start Date
November 20 2018
End Date
April 30 2020
Last Update
December 27 2023
Active Locations (1)
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1
Henan Provincial Center for Disease Control and Prevention
Zhaoge, Henan, China, 450016