A Clinical Study of a Zoster Vaccine in Healthy Adults >= 40 Years
NCT ID: NCT04072497
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
522 participants
INTERVENTIONAL
2018-11-20
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Zoster vaccine, Live
live attenuated varicella-zoster virus vaccine (with live virus \>=4.3 LgPFU per dose)
One shot of the zoster vaccine
One shot of the zoster vaccine (with live virus \>=4.3 LgPFU per dose)
Varicella vaccine, Live
live attenuated varicella-zoster virus vaccine (with live virus \>=3.3 LgPFU per dose)
One shot of the varicella vaccine
One shot of the varicella vaccine (with live virus \>=3.3 LgPFU per dose)
Placebo
Placebo with no live virus
one shot of placebo
one shot of placebo with no live virus
Interventions
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One shot of the zoster vaccine
One shot of the zoster vaccine (with live virus \>=4.3 LgPFU per dose)
One shot of the varicella vaccine
One shot of the varicella vaccine (with live virus \>=3.3 LgPFU per dose)
one shot of placebo
one shot of placebo with no live virus
Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
ALL
Yes
Sponsors
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Shanghai Institute Of Biological Products
INDUSTRY
Responsible Party
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Locations
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Henan Provincial Center for Disease Control and Prevention
Zhaoge, Henan, China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017L04524-Ⅰ/Ⅱ
Identifier Type: -
Identifier Source: org_study_id