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A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years

This study is currently Recruiting

April 2011 By Xiamen University

First Recieved on May 13, 2011

Last Updated on May 17, 2011

Sponsor: Xiamen University
Collaborators: Xiamen Innovax Biotech Co., Ltd
Information provided by: Xiamen University
Identifier: NCT01356823

Purpose

This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The aim of this study is to evaluate the immunogenicity and safety of different vaccine dosage in healthy women 18-25 years of age at enrolment. Approximately 1600 study subjects will be enrolled and randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV) vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Eligibility

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

Inclusion Criteria: - Written informed consent from the subject prior to enrolment; - Female between, and including, 18 and 25 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;

Investigators

  • Investigator: Jun Zhang, Master - Study Chair - Xiamen University
  • Investigator: Yuemei Hu, Bachelor - Principal Investigator - Jiangsu Provincial Centre for Disease Control and Prevention
  • Investigator: Ting Wu, Ph. D - Study Director - Xiamen University

Locations

  • Jiangsu Provincial Centre for Disease Control and Prevention

    Nanjing, Jiangsu 210009 China

Conditions related to this trial:

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