Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

This study has been completed.
Sponsor:
Collaborators:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Information provided by (Responsible Party):
Jun Zhang, Xiamen University
ClinicalTrials.gov Identifier:
NCT01263327
First received: December 17, 2010
Last updated: February 20, 2014
Last verified: February 2014

December 17, 2010
February 20, 2014
December 2010
July 2011   (final data collection date for primary outcome measure)
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. [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01263327 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Cervical Cancer
Biological: HPV 16/18
Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Experimental: HPV 16/18
Participants in this arm would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
Intervention: Biological: HPV 16/18
Hu YM, Huang SJ, Chu K, Wu T, Wang ZZ, Yang CL, Cai JP, Jiang HM, Wang YJ, Guo M, Liu XH, Huang HJ, Zhu FC, Zhang J, Xia NS. Safety of an Escherichia coli-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine: An open-label phase I clinical trial. Hum Vaccin Immunother. 2013 Oct 25;10(2). [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
July 2011
July 2011   (final data collection date for primary outcome measure)

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;
Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01263327
HPV-PRO-001
No
Jun Zhang, Xiamen University
Xiamen University
  • Xiamen Innovax Biotech Co., Ltd
  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Principal Investigator: Yue-mei Hu, Bachelor Jiangsu Provincial Centre for Disease Control and Prevention
Xiamen University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP