NCT03935204

Immunogenicity Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

An Randomized, Double-Blinded, Placebo Controlled Phase II Clinical Trial to Estimate Immunogenicity of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Adults Aged 18 to 45 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 627 (actual)
• Sponsor: Xiamen University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This phase II clinical study was designed to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.

Conditions

• Condylomata Acuminata
• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	HPV Vaccine,270μg/1.0ml	HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
BIOLOGICAL	Placebo	Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Timeline

• Start date: 2019-05-13
• Primary completion: 2019-10-18
• Completion: 2021-04-01
• First posted: 2019-05-02
• Last updated: 2021-04-08

Locations

1 site across 1 country: China