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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Jun Zhang

Current Primary Outcome: Measure adverse reactions/events throughout the study [ Time Frame: 10 month ]

With composite measure: Measure solicited local/systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure blood, liver and kidney function changes pre- and 2 days post vaccination; Measure serious adverse events occurred throughout the study


Original Primary Outcome: Same as current

Current Secondary Outcome: Measure anti-HPV 6/11 antibody in serum samples at 7 month to evaluate the immunogenicity of the HPV 6/11 vaccine formulations. [ Time Frame: 7 month ]

Original Secondary Outcome: Same as current

Information By: Xiamen University

Dates:
Date Received: March 25, 2015
Date Started: March 2015
Date Completion: September 2016
Last Updated: July 13, 2016
Last Verified: December 2015