This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
160
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China
Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions.
Time frame: 7 days after each vaccine dose
Occurrence, intensity and relationship to vaccination of any unsolicited symptom.
Time frame: 30 days after finish vaccinations
Neutralizing antibody responses of HPV 16/18 after each vaccine dose.
Time frame: 30 days after finish vaccinations
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Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.