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Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent(Type 16/18 )Vaccine

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ClinicalTrials.gov Identifier: NCT01735006
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : February 24, 2020
Sponsor:
Collaborators:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Jun Zhang, Xiamen University

Tracking Information
First Submitted Date  ICMJE November 18, 2012
First Posted Date  ICMJE November 28, 2012
Last Update Posted Date February 24, 2020
Actual Study Start Date  ICMJE November 22, 2012
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2012)
  • Number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection [ Time Frame: expected 5-6 years ]
  • Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) [ Time Frame: expected 2-3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2012)
  • Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: Within 7 days after each vaccination ]
  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Month 7 ]
  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: expected 5-6 years ]
  • number of subjects with persistent cervical infection (12-month+ definition)associated with HPV-16 and/or HPV-18 [ Time Frame: expected 5-6 years ]
  • number of subjects Histopathologically-confirmed CIN1+ and/or VIN1+ and/or VaIN1+ associated with HPV-16 and/or -18 cervical infection [ Time Frame: expected 5-6 years ]
  • number of subjects with incidence infection associated with HPV-16 and/or HPV-18 [ Time Frame: expected 2-3 years ]
  • Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 [ Time Frame: month 7 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 23, 2012)
Number of subjects histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types [ Time Frame: expected 5-6 years ]
Histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types (e.g. HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) detected within the lesional component of the tissue specimen (by PCR).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent(Type 16/18 )Vaccine
Official Title  ICMJE A Phase III Multicenter, Randomized, Double-Blind, Placebo(Hepatitis E Vaccine)Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant(E.Coli)Human Papillomavirus Bivalent Vaccine in Healthy Women
Brief Summary This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cervical Intraepithelial Neoplasia
  • Cervical Cancer
  • Vaginal Intraepithelial Neoplasia
  • Vulvar Intraepithelial Neoplasia
  • Persistent Infection
Intervention  ICMJE
  • Biological: HPV Vaccine
    3 doses at month 0,1 and 6
  • Biological: HEV vaccine
    3 doses at month 0,1 and 6
    Other Name: Hecolin
Study Arms  ICMJE
  • Experimental: HPV vaccine
    This dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant
    Intervention: Biological: HPV Vaccine
  • Placebo Comparator: HEV vaccine
    commercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant
    Intervention: Biological: HEV vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2018)
7372
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2012)
6000
Actual Study Completion Date  ICMJE October 18, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female subjects between, and including, 18 and 45 years of age at the first vaccination;
  2. Healthy subjects as established by medical history and history-oriented clinical examination;
  3. Be able to understand and comply with the request of the protocol;
  4. Without acute cervicitis;
  5. Not pregnant;
  6. Have intact cervix.

Exclusion Criteria:

  1. Use of any investigational or non-registered product (drug or vaccine)within 30 days preceding the first vaccination, or plan to use during the study period;
  2. Are using immunosuppressants;
  3. Administration of immunoglobulin and/or any blood products within the three months preceding the first vaccination or planned administration during the study period;
  4. Vaccinated of inactivated vaccine 14 days or attenuated vaccine 21 days before the enrollment;
  5. Fever;
  6. Concurrently participating another clinical trial;
  7. Has received vaccines against HPV 16/18 ;
  8. Immunodeficient;
  9. History of allergic disease;
  10. Serious medical disorders;
  11. Blood coagulation disorders;
  12. Epilepsy;
  13. Unable to comply with protocol due to the mental illness;
  14. Visible Condyloma;
  15. Pregnant or breast-feeding women;
  16. vergins;
  17. Have more than 4 sexual partners.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01735006
Other Study ID Numbers  ICMJE HPV-PRO-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jun Zhang, Xiamen University
Study Sponsor  ICMJE Xiamen University
Collaborators  ICMJE
  • Xiamen Innovax Biotech Co., Ltd
  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
  • Ministry of Science and Technology of the People´s Republic of China
Investigators  ICMJE
Study Chair: Jun Zhang, Master Xiamen University
Principal Investigator: Youlin Qiao, Ph.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Director: Ting Wu, Ph. D Xiamen University
PRS Account Xiamen University
Verification Date February 2020

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