This study is to evaluate lot-lot consistency of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) .
This study is a mono-center, randomization, double-blind clinical trial in healthy Female subjects between 9 to 14. Under the premise of full informed consent, 540 subjects that meet the requirement of clinical trial in the age of 9-14 will be randomly divided into 3 groups in a ratio of 1:1:1 and injected 2 consecutive batches of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) Cecolin® separately. The main outcome measures are the immunogenicity consistency and safety surveillance after inoculation according to prescribed immunization procedure.The total number of subjects should be ≥540 and ≤570.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
540
The bivalent HPV 16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with aluminum adjuvant.
Dongtai City Center for Disease Control and Prevention Dongtai, Jiangsu
Dongtai, Jiangsu, China
The Geometric Mean concentration (GMC) of anti-HPV16/18 IgG at at one month after the 2nd dose.
Measure anti-HPV16/18 IgG in serum samples at 7 month to evaluate the immunogenicity of the HPV vaccine.
Time frame: 7 months
Seroconversion rate of anti-HPV16/18 IgG at one month after the 2nd dose.
Describe seroconversion rate of anti-HPV16/18 IgG one month after the last dose.
Time frame: 7 months
Measure solicited local adverse reactions within 7 days after each vaccination.
Time frame: 7 days
Measure solicited systematic adverse reactions within 7 days after each vaccination.
Time frame: 7 days
Measure unsolicited adverse reactions within 30 days after vaccination.
Time frame: 30 days
Measure serious adverse events occurred throughout the study.
Time frame: up to 7 months
Measure Potential Immune Mediated Diseases occurred throughout the study.
The Potential Immune Mediated Diseases refers to a disease of immune hyperfunction or immune deficiency caused by immune regulation disorder due to insufficient transmission of certain immune mediates, such as Guillain-Barre syndrome and thrombocytopenic purpura.
Time frame: up to 7 months
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