NCT05580341

Phase III Study Comparing the Immunogenicity of 9-valent HPV Recombinant Vaccine and Gardasil-9

A Phase III, Randomized, Blinded, Positive-controlled Study to Compare the Immunogenicity of Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris) in Healthy Female Subjects Aged 16-26 Years.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Shanghai Zerun Biotechnology Co.,Ltd · Industry
• Sex: Female
• Age: 16 Years – 26 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9.

Conditions

• Cervical Cancer
• Genital Wart
• CIN
• VIN
• Papillomavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	Zerun HPV-9	Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris), 0.5mL, three doses, 0,2,6 months
BIOLOGICAL	GARDASIL ®9	GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2022-10-14
• Last updated: 2022-10-28

Locations

1 site across 1 country: China