NCT03676101

Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Primary Immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Shanghai Bovax Biotechnology Co., Ltd. · Industry
• Sex: Female
• Age: 9 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.

Conditions

• Cervical Cancers
• Vulvar Cancer
• Vaginal Cancer
• CIN1
• CIN2
• CIN 3
• AIS
• Invasive Carcinoma
• Mild Dysplasia of Vulva
• Moderate Dysplasia of Vulva
• Vin III
• VaIN1
• VaIN2
• VaIN3
• Genital Wart

Interventions

Type	Name	Description
BIOLOGICAL	9-valent HPV Recombinant Vaccine	Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
BIOLOGICAL	Placebo	Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.

Timeline

• Start date: 2018-10-10
• Primary completion: 2019-08-20
• Completion: 2020-01-10
• First posted: 2018-09-18
• Last updated: 2020-01-22

Locations

1 site across 1 country: China