Phase 2Completed
A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine
A Phase II Trial in Healthy Chinese Women Ages 20-45 to Evaluate the Immunogenicity and Safety Profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)
- Sponsor
- Beijing Health Guard Biotechnology, Inc (Industry)
- Enrolment
- 780 enrolled
- Conditions
- Human Papilloma Virus Infection
- Interventions
- Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli); Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)
- Ages
- adults
- Registry
- NCT05694728
Full record on ClinicalTrials.gov
From the registry
This trail is to evaluate the safety profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy Chinese women ages 20-45 and determine the optimal ratio of the antigens included in the investigational vaccine. Besides, the trail is also to demonstrate that the levels of neutralizing antibodies to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the investigational vaccine with the chosen optimal antigen ratio are superior to those induced by Gardasil.
Primary outcomes
- Percentage of adverse reactions up to Day 7 after each dose of the interventions
- To determine the optimal ratio of antigens included in the investigational vaccine
History
Registered
Study completion
Primary completion
Started