The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,680
Subjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule.
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
Subjects received 3 doses of GARDASIL® according to a 0, 2, 6-month schedule.
Yangchun Center For Disease Prevention And Control
Yangchun, Guangdong, China
Percentage of participants 20 to 45 Years of Age that achieve the neutralizing antibody serostatus cutoffs for seroconversion to HPV Types 6, 11, 16 and 18 at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
The neutralizing antibody GMTs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth ratefor HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth rate or achieve the neutralizing antibody serostatus cutoffs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
The neutralizing antibody GMTs for HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth ratefor HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
Percentage of participants that achieve neutralizing antibody quadruple growth rate or achieve the neutralizing antibody serostatus cutoffs for HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.
Time frame: 1 month post vaccination 3 (Month 7)
Percentage of Participants Who Report at Least 1 Solicited Injection-site and Systemic Adverse Event 30 minutes post any vaccination
Time frame: 30 minutes post any vaccination
Percentage of Participants Who Report at Least 1 Solicited Adverse Event 7 days post any vaccination
Time frame: 7 days post any vaccination
Percentage of Participants Who Report at Least 1 Solicited and Unsolicited Adverse Event 30 days post any vaccination
Time frame: 30 days post any vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) from 1st vaccination to the completion of study
Time frame: Day 1 to 6 months post vaccination 3
Percentage of Participants Who Experience Pregnancy from 1st vaccination to the completion of study
Time frame: Day 1 to 6 months post vaccination 3
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