A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccin… (NCT07293065) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell)
China12,000 participantsStarted 2025-12-15
Plain-language summary
The purpose of the sutdy is to evaluate the protective efficacy of Recombinant Herpes Zoster Vaccine (CHO Cell) (hereinafter referred to as "the investigational vaccine") in preventing herpes zoster at 13-36 months after complete immunization with the 0- and 2-month immunization schedule in individuals aged 40 years and older.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants in the MKKCT-100-003 study who have completed two doses of the investigational vaccine;
. Males or females able to provide legal identity certificate;
. Participants voluntarily agree to participate in the study, and sign the informed consent form;
. Able to understand the study procedures and participate in all scheduled follow-up visits, and able to comply with the protocol requirements (such as cooperating in filling out questionnaires/scales, and being regularly contacted during the study for evaluation, etc.).
Exclusion criteria
. Participants who plan to use any products (drugs, vaccines, or medical devices) other than the investigational product for the prevention of VZV infection before signing the informed consent form or during the study period;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The person-year incidence of confirmed herpes zoster cases among individuals aged 40 years and older, 13 to 36 months after completing the full vaccination course with the investigational vaccine according to the 0- and 2-month immunization schedule.
Timeframe: At 13~36 months after the last vaccination
Trial details
NCT IDNCT07293065
SponsorMAXVAX Biotechnology Limited Liability Company
. Participants with any confirmed or suspected immunosuppressive or immunodeficiency condition caused by diseases (e.g., malignant tumors, human immunodeficiency virus infections, etc.) or immunosuppressive/cytotoxic treatments (e.g., medications used during cancer chemotherapy, organ transplantation, or treatment of autoimmune diseases);
. Participants who are currently participating in or plan to participate in other clinical trials during the study;
. Significant underlying diseases or any other condition that, in the opinion of the investigator, may prevent completion of the trial.