NCT02888418

Safety and Immunogenicity Study of Human Papilloma Virus Vaccine in Women Aged 9 to 30 and Men Aged 9 to 17

Random, Double Blind, Placebo Controlled Phase I Clinical Trials to Estimate the Safety and Preliminary Immunogenicity of Tetravalent Recombinant Human Papilloma Virus Vaccine (6,11,16,18 Type)(Hansenula Polymorpha) in Women of 9 to 30 Years Old and Men of 9 to 17 Years Old

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention · Academic / Other
• Sex: All
• Age: 9 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the safety of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in women of 9 to 30 years old and men of 9 to 17 years old and preliminarily explore the immunogenicity. 135 people are enrolled in total, including 45 women of 18 to 30 years old and 90 people of 9 to 17 years old. Among the first group, 30 women will be inoculated studied vaccine and 15 women will be inoculated placebo. Among the second group, there are 45 women and 45 men, 30 women and 30 men in vaccine group and 15 women and 15 men in placebo group.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)	Injection vaccine produced by Beijing institute of biological products co., LTD, containing HPV antigen protein, 120μg/0.5ml/bottle
BIOLOGICAL	placebo

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2016-09-05
• Last updated: 2016-09-05