NCT01548118

Evaluate the Safety of Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Healthy Females

A Blind, Randomized and Placebo-controlled Clinical Trial With Recombinant HumanPapillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Health Women-Phase I

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Shanghai Zerun Biotechnology Co.,Ltd · Industry
• Sex: Female
• Age: 9 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.

Conditions

• Human Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	HPV 16/18 vaccine, 0,5ml	Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
BIOLOGICAL	Placebo control, 0.5ml	Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
BIOLOGICAL	HPV 16/18 vaccine, 1.0ml	Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
BIOLOGICAL	Placebo control, 1.0ml	Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2012-03-08
• Last updated: 2012-03-08

Locations

1 site across 1 country: China