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A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

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ClinicalTrials.gov Identifier: NCT02562508
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : August 16, 2018
Sponsor:
Collaborators:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Information provided by (Responsible Party):
Jun Zhang, Xiamen University

Tracking Information
First Submitted Date  ICMJE September 14, 2015
First Posted Date  ICMJE September 29, 2015
Last Update Posted Date August 16, 2018
Actual Study Start Date  ICMJE December 5, 2015
Actual Primary Completion Date August 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody) [ Time Frame: Month 7 ]
To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on day 0 (before the 1st dose) ,six month after the dose 1 (before the 3rd dose) and one month after dose 3
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2015)
Number of Participants with Adverse Events [ Time Frame: Month 7 ]
All the adverse events in one month after each dose would be recorded in the diary card. All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 25, 2015)
Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody) [ Time Frame: Month 7 ]
To detect the anti-HPV 16 and anti-HPV 18 type specific neutralizing antibody level on day 0 (before the 1st dose) ,six month after the dose 1 (before the 3rd dose) and one month after dose 3
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls
Official Title  ICMJE Immunogenicity and Safety Study of a Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 Years
Brief Summary This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).
Detailed Description Totally 750 healthy girls of 9-17 years and 225 healthy young women of 18-26 years were enrolled. The subjects of 9-14 years will be stratified into 2 subset. Subjects in each subsets will be randomly assigned into the standard 0-1-6m schedule group or an alternative 0-6m group. All subjects of 15-26 years of age will receive the standard 0-1-6m schedule. Participants were actively monitored for adverse events for 1 month after each injection. Severe adverse events during the trial were followed up. Serum samples from all the subjects would be collected on day 0, 6m, 7m to evaluate the immunogenicity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cervical Intraepithelial Neoplasia
  • Cervical Cancer
  • Vaginal Intraepithelial Neoplasia
  • Vulvar Intraepithelial Neoplasia
  • Persistent Infection
Intervention  ICMJE
  • Procedure: 3 doses of HPV 16/18 bivalent vaccine
    Participants would receive 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
  • Procedure: 2 doses of HPV 16/18 bivalent vaccine
    Participants would receive 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)
Study Arms  ICMJE
  • Experimental: 9-17y (0,1,6m)
    Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
    Intervention: Procedure: 3 doses of HPV 16/18 bivalent vaccine
  • Experimental: 9-14y (0,6m)
    Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine
    Intervention: Procedure: 2 doses of HPV 16/18 bivalent vaccine
  • Experimental: 18-26y (0,1,6m)
    Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
    Intervention: Procedure: 3 doses of HPV 16/18 bivalent 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: December 29, 2015)
979
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2015)
975
Actual Study Completion Date  ICMJE August 12, 2016
Actual Primary Completion Date August 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Females aged between 9 and 26 years when they receive the first vaccination (9≤age<27);
  2. Participants aged 9-17 years whose legal guardian can provide identity certificate, or representative can provide authorization;
  3. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations;
  4. Participants aged 9-17 years, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18-26 years and agree to sign the written informed consent;
  5. Able to comply with the requests of the study;
  6. Axillary temperature not higher than 37.0°C;
  7. Nonpregnancy verified by a urine pregnancy test;

Exclusion criteria:

  1. Pregnant or lactating woman and any woman who are willing or intend to become pregnant in next 7 months;
  2. 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;
  3. Participants who received an immunosuppressive agent or other immunomodulator agent for a long term (for 14 days or more) within 6 months of the first vaccination, or systematic corticosteroid (however, a topical corticosteroid is allowed, such as ointment, eye drops, inhalant, or nasal spray);
  4. Participants who received immunoglobulin and/or blood product 3 months prior to the first vaccination, or planned to receive during the study period;
  5. Use of any inactivated vaccine 14 days preceding dosing of study vaccine or attenuated vaccine 21 days before the enrollment;
  6. Participants had fever (auxiliary temperature ≥38.0 °C) within 3 days prior to vaccination, or any acute disease requiring systematic antibiotics or antiviral therapy within the past 5 days;
  7. Concurrently participating another clinical trial;
  8. Participants who have received HPV vaccines;
  9. Participants with immunodeficiency disease (such as HIV positive), primary disease in vital organs, cancer (or precancerous lesion), or chronic history of immunological disease requiring treatment (including systemic lupus erythematosus), rheumatoid arthritis, asplenia or splenectomy due to any conditions, and other immunological diseases that may impact immune response as considered by investigator), etc.;
  10. Participants with a history of allergy, including severe adverse reactions due to the past vaccination, such as hypersensitivity, urticaria, dyspnea, angioneurotic edema, or abdominal pain;
  11. Participants with asthma, which is unstable in the past 2 years, requiring emergency treatment, hospitalization, or oral or intravenous corticosteroid;
  12. Participants with concurrent severe medical disorders, such as hypertension, heart disease, diabetes mellitus, or hyperthyroidism, etc.;
  13. Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician;
  14. Participants with epilepsy, excluding febrile epilepsy in patients under 2 years old, alcoholic epilepsy 3 years prior to alcohol abstinence, or pure epilepsy requiring no treatment within the past 3 years;
  15. Participants who are not compliant to the study's requirements due to psychological conditions, or those with prior or existing mental disease or bipolar psychosis which are not well controlled within the past 2 years and require taking drugs, or those with suicidal tendency within the past 5 years;
  16. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 9 Years to 26 Years   (Child, 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 NCT02562508
Other Study ID Numbers  ICMJE HPV-PRO-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jun Zhang, Xiamen University
Study Sponsor  ICMJE Jun Zhang
Collaborators  ICMJE
  • Xiamen Innovax Biotech Co., Ltd
  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Investigators  ICMJE
Study Chair: Ting Wu, Ph. D. Xiamen University
Principal Investigator: Yuemei Hu, Bachelor Jiangsu Provincial Centre for Disease Control and Prevention
PRS Account Xiamen University
Verification Date August 2018

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