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.
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.
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;
Parallel
Recombinant Zoster Vaccine (CHO Cell)
Biological/Vaccine0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with MA105. Intramuscular injection
The geometric mean concentration (GMC) of anti-gE antibodies one month after full vaccination.
Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter.
The seroconversion rate of anti-gE antibodies one month after full vaccination.
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
The incidence, severity, and vaccine-related association of solicited local adverse events (AEs) within 7 days after each dose of vaccination.
This typically refers to the documentation and assessment of local adverse events (such as pain and swelling at the injection site) that occur within 7 days after vaccination in clinical studies or vaccination programs. This includes the frequency of occurrence, severity (usually categorized as mild, moderate, and severe), and the investigator's assessment of the association between these events and vaccination.
The incidence, severity, and relevance to vaccination of solicited general adverse events (AEs) within 7 days after each dose of vaccination.
This typically refers to the documentation and assessment of general adverse events that occur within the 7-day observation period after each vaccination dose, including the frequency of occurrence, severity (such as mild, moderate, and severe), and the investigator's assessment of the association between these events and the vaccination.
The incidence, severity, and relevance to vaccination of unsolicited adverse events (AEs) within 30 days after each vaccine dose.
This typically refers to the documentation and assessment of unexpected adverse events that occur within the 30-day observation period after each vaccine dose, including the frequency of occurrence, severity (such as mild, moderate, and severe), and the investigator's assessment of the association between these events and vaccination.
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