A Phase 3 interventional study of 4-valent HPV Vaccine and 9-valent HPV Vaccine in Cervical Cancer, Vulvar Cancer and Vaginal Cancer, sponsored by Shanghai Bovax Biotechnology Co., Ltd.. Completed at 1 site in China. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-25.
Sponsored by Shanghai Bovax Biotechnology Co., Ltd. · Phase 3, Interventional, and Prevention
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.
94 studies on the registry are indexed under Condylomata Acuminata; 7 are open to participants now.
This study's enrollment of 1,680 is above the median of 140 across 77 interventional studies indexed under Condylomata Acuminata.
Browse Condylomata Acuminata studies →Shanghai Bovax Biotechnology Co., Ltd. is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm would receive 4-valent Human Papillomavirus (Types 6, 11, 16 and18) Recombinant Vaccine (Hansenula Polymorpha)
Biological: 4-valent HPV Vaccine
Participants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)
Biological: 9-valent HPV Vaccine
Participants in this arm would receive GARDASIL®
Biological: GARDASIL®
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.
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
Plan to share: No
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Bovax Biotechnology Co., Ltd.