Phase III Clinical Trial of Lot-to-lot Consistency of Recombinant Herpes Zoster Vaccine (CHO Cell).

ConditionHerpes Zoster
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorMAXVAX Biotechnology Limited Liability Company

About this trial

To evaluate the lot-to lot consistency of three batches of recombinant herpes zoster vaccine (CHO cell) produced on a commercial scale in subjects aged 40 years and older after receiving 2 doses on a 0, 2 month schedule.

Eligibility criteria

Qualifiers

A male or female permanent resident aged 40 years and older at enrollment, with valid identity;

Subjects voluntarily agree to participate in the study and signed an informed consent;

Be able to understand clinical trials, participate in all scheduled visits and comply with the protocol requirements(e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);

Women of childbearing potential plan to avoid pregnancy and are willing to use effective contraception(e.g. oral contraceptive pills, injectable progestogen, percutaneous contraceptive patches, implants of levonorgestrel, intrauterine device, female and male sterilization or abstinence) within 12 months after the last vaccination, and the uses of the rhythm method alone, withdrawal alone, and emergency contraception, are not acceptable.

Disqualifiers

Axillary temperature > 37.0°C on the day of vaccination or acute illness;

Current or history of herpes zoster;

Previous vaccination against varicella or herpes zoster (either registered product or participation in a previous vaccine study);

Pregnant (urine pregnancy test was positive) or lactating female;

Trial design

Treatments tested in this trial

  • Recombinant Zoster Vaccine (CHO Cell)

Treatment groups

1,200 Participants
are divided into 3 treatment groups