Clinical Trial: Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A PhaseⅡ Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Age

Brief Summary: This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6 month schedule. This is a double-blind study.

Detailed Summary:
Sponsor: Jun Zhang

Current Primary Outcome:

  • Anti-HPV 6 and anti-HPV 11 seroconversion rates (type specific IgG antibody) [ Time Frame: 7 months ]
  • Anti-HPV 6 and anti-HPV 11 geometric mean concentrations (type specific IgG antibody) [ Time Frame: 7 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of serious adverse events throughout the study [ Time Frame: 7 months ]

All the serious adverse events throughout the study would be recorded.


Original Secondary Outcome: Same as current

Information By: Xiamen University

Dates:
Date Received: January 27, 2016
Date Started: March 2016
Date Completion: November 2016
Last Updated: March 12, 2016
Last Verified: March 2016