Safety and Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine
- Conditions
- Condylomata Acuminata
- Registration Number
- NCT02405520
- Lead Sponsor
- Jun Zhang
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Measure adverse reactions/events throughout the study 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
- Secondary Outcome Measures
Name Time Method Measure anti-HPV 6/11 antibody in serum samples at 7 month to evaluate the immunogenicity of the HPV 6/11 vaccine formulations. 7 month