The goal of this clinical trial is to evaluate the lot-to-lot consistency, immunogenicity, and safety of live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.
This trial is aim to evaluate the lot-to-lot consistency, immunogenicity, and safety of live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy people 1 to 12 years of age.1200 healthy subjects aged 1-12 years were enrolled after their guardians passed the informed consent, inclusion and exclusion criteria screening in turn. Three batches were randomized in a 1:1: 1 ratio, with 400 subjects in each batch.All subjects received 1 dose of trial vaccine (Batch 1 or Batch 2 or Batch 3) and all were collected Blood samples were collected from subjects before vaccination, on Day 30 after vaccination for serum neutralizing antibody testing to evaluate immunogenicity, and Safety observations were performed until 6 months post-vaccination in all subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,200
0.5ml/vial
0.5ml/vial
0.5ml/vial
Xinyi Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies
Geometric mean titers (GMT) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization
Time frame: 30 days after vaccination
Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies
Positive conversion rate and geometric mean fold increase (GMFI) of anti-VZV neutralizing antibodies 30 days after vaccination in the negative population before immunization
Time frame: 30 days after vaccination
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies
Positive conversion rate, GMT, and GMFI of anti-VZV neutralizing antibodies 30 days after vaccination in the whole population
Time frame: 30 days after vaccination
The incidences of adverse events (AEs)
AEs occurred witnin 30 days after vaccination will be collected
Time frame: 30 days after vaccination
The incidences of serious adverse events (SAEs) and Adverse Event of Special Interest(AESI)
SAEs and AESI occurred witnin 6 months after vaccination will be collected
Time frame: 6 months after vaccination
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