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Not yet recruiting NCT06961721

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of a Live Attenuated Herpes Zoster Vaccine in Adults Aged 40 Years and Older

Phase IV Interventional Prevention of Herpes Zoster

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Herpes Zoster Vaccine, Live, Placebo.
Who it may be relevant to
Registry conditions: Prevention of Herpes Zoster. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

To evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine. To evaluate the safety of the live attenuated herpes zoster vaccine.

Interventions

  • Biological Herpes Zoster Vaccine, Live
    assigned to the vaccine group and placebo group in a 2:1 ratio.
  • Biological Placebo
    assigned to the vaccine group and placebo group in a 2:1 ratio.

Primary outcome measures

  • Immunogenicity: [Time frame: Day 0 and Day 42]
  • Immunogenicity: [Time frame: Day 0 and Day 42]
  • Immunogenicity: [Time frame: Day 0 and Day 42]
  • Immunogenicity: [Time frame: Day 0 and Day 42]
Secondary outcome measures (1)
  • Adverse Events [Time frame: 42 days]

Eligibility criteria

Inclusion criteria

  • Age ≥40 years on enrollment day；
  • The informed consent of the subject can be obtained and signed；
  • The subjects themselves were able to complete the trial in accordance with the requirements of the clinical trial protocol；
  • Armpit body temperature ≤37.0℃ on the day of enrollment.

Exclusion criteria

  • People who are immune deficient or immunosuppressed due to certain diseases or treatments. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency conditions, such as AIDS or other diseases caused by viral infection; Leukemia, lymphoma, or other malignancies affecting the bone marrow or lymphatic system; Being treated for immunosuppression; Being treated with radiation/chemotherapy for a tumor；
  • Do not use in persons with a history of allergic reaction to any of the components contained in this product；
  • Those who are in the acute stage of acute infection and chronic infection should postpone the vaccination of this product；
  • Premenopausal women who tested positive for pregnancy, pregnant women, breastfeeding women, or those who planned to have a baby within 6 months；
  • If this product and other injectable live attenuated vaccines are not administered at the same time, the interval should be at least 28 days；
  • Treatment with whole blood, plasma, or immunoglobulin is given within 5 months or 3 weeks prior to vaccination；
  • Received another investigational drug within 1 month prior to receiving the investigational vaccine/placebo, or is participating in another clinical trial, or plans to use it during the study；
  • Taking or about to take salicylate drugs, including aspirin and difluorosalicylic acid；
  • Patients with abnormal blood pressure that cannot be controlled by medication (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)；
  • Previous vaccinations against chickenpox or shingles (including use of registered products or participation in clinical trials of chickenpox or shingles vaccine)；
  • Any situation that the investigator considers likely to affect the evaluation of the trial。

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06961721 · PFDP20241008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗