Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
Phase 1
Completed
- Conditions
- Cervical Cancer
- Registration Number
- NCT01263327
- Lead Sponsor
- Xiamen University
- Brief Summary
This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 38
Inclusion Criteria
- Written informed consent from the subject prior to enrolment;
- Female between, and including, 18 and 55 years of age at the time of enrolment;
- Subjects must be free of obvious health problems;
- Not pregnant and having no plan for pregnancy;
Exclusion Criteria
- Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
- Previous vaccination against HPV;
- Having severe allergic history or other immunodeficiency;
- Chemotherapy and other immunosuppressive agents using;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Measure injection-site complaints within 7 days after each vaccination; Measure systematic adverse reactions within 1 month after vaccination; Measure serious adverse experience; Measure blood, liver and kidney functions pre- and 3 days post vaccination. 7 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jiangsu Provincial Centre for Disease Control and Prevention
🇨🇳Dongtai, Jiangsu, China
Jiangsu Provincial Centre for Disease Control and Prevention🇨🇳Dongtai, Jiangsu, China