Status:
COMPLETED
Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
Lead Sponsor:
Xiamen University
Collaborating Sponsors:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
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 a...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01263327
Start Date
December 1 2010
End Date
July 1 2011
Last Update
July 10 2020
Active Locations (1)
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1
Jiangsu Provincial Centre for Disease Control and Prevention
Dongtai, Jiangsu, China, 224200