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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorChangchun BCHT Biotechnology Co.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Herpes Zoster Vaccine, Live
  • Placebo

Treatment groups

600 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Changchun BCHT Biotechnology Co.

Lead sponsor

Inner Mongolia Center for Disease Control and Prevention

Collaborator

Center for Disease Control and Prevention, Fujian

Collaborator