Status:
COMPLETED
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
Herpes Zoster
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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.
- For females only (40-49 years), a negative urine pregnancy test and willing to practice continuous effective contraception during the study.
- 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 attenuated vaccine in last 28 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\>37.0°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.
- Any other conditions may compromise the safety or availability of participants in the judgment of the investigator.
Key Trial Info
Start Date :
October 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2019
Estimated Enrollment :
30000 Patients enrolled
Trial Details
Trial ID
NCT03314103
Start Date
October 6 2017
End Date
January 19 2019
Last Update
March 30 2021
Active Locations (3)
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1
Hunan Provincial Center for Disease Control and Prevention
Loudi, Hunan, China, 417000
2
Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009
3
Zhejiang Provincial Center for Disease Control and Prevention
Hanzhou, Zhejiang, China, 310051