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 total of 1200 subjects aged 40 years and older were randomly assigned in a 1:1:1 ratio to three commercial-scale batches (batch 1, batch 2, Batch 3) , with 400 subjects in each group. To demonstrate lot-to-lot consistency in terms of anti-gE antibody GMC between three production lots of the HZ vaccine one month after the second dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,200
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with MA105. Intramuscular injection
Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, China
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.
Time frame: At Month 0 and Month 3.
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.
Time frame: At Month 3.
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.
Time frame: During the 7 days (Days 0-6) after each vaccine dose.
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.
Time frame: During the 7 days (Days 0-6) after each vaccine dose.
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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.
Time frame: During 30 days (Days 0-29) after each vaccination.
The incidence of serious adverse events (SAEs) from the first dose of vaccination to one month after the final dose.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3).
The incidence of potential immune-mediated diseases (pIMDs) from the first dose of vaccination to one month after the final dose.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3).