Cervical Cancer Clinical Trial
Official title:
Random, Double Blind, Placebo Controlled Phase I Clinical Trials to Estimate the Safety and Preliminary Immunogenicity of Tetravalent Recombinant Human Papilloma Virus Vaccine (6,11,16,18 Type)(Hansenula Polymorpha) in Women of 9 to 30 Years Old and Men of 9 to 17 Years Old
This study evaluates the safety of Tetravalent recombinant human papilloma virus vaccine
(6,11,16,18 type) (Hansenula polymorpha) in women of 9 to 30 years old and men of 9 to 17
years old and preliminarily explore the immunogenicity.
135 people are enrolled in total, including 45 women of 18 to 30 years old and 90 people of
9 to 17 years old. Among the first group, 30 women will be inoculated studied vaccine and 15
women will be inoculated placebo. Among the second group, there are 45 women and 45 men, 30
women and 30 men in vaccine group and 15 women and 15 men in placebo group.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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