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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Xiamen University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd
Information provided by:
Xiamen University
ClinicalTrials.gov Identifier:
NCT01263327
First received: December 17, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

This phase I clinical study will 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.


Condition Intervention Phase
Human Papillomavirus 16
Human Papillomavirus 18
 Biological: Human Papillomavirus Virus 16/18 Bivalent Vaccine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xiamen University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human Papillomavirus Virus 16/18 Bivalent Vaccine Biological: Human Papillomavirus Virus 16/18 Bivalent Vaccine
administered intramuscularly according to a 0-1-6 month schedule

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263327

Contacts
Contact: Yue-mei Hu, Bachelor 86-25-83759399 huyuemei@hotmail.com

Locations
China, Jiangsu
Jiangsu Provincial Centre for Disease Control and Prevention Recruiting
Dongtai, Jiangsu, China, 224200
Contact: Yue-mei Hu, Bachelor     86-25-83759399     huyuemei@hotmail.com    
Principal Investigator: Yue-mei Hu, Bachelor            
Sponsors and Collaborators
Xiamen University
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd
Investigators
Principal Investigator: Yue-mei Hu, Bachelor Jiangsu Provincial Centre for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Ting Wu/Dr, Xiamen University
ClinicalTrials.gov Identifier: NCT01263327     History of Changes
Other Study ID Numbers: HPV-PRO-001
Study First Received: December 17, 2010
Last Updated: December 17, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Xiamen University:
human papillomavirus vaccine

ClinicalTrials.gov processed this record on June 18, 2013