Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

Brief Title

Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

Official Title

A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Primary Immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years

Brief Summary

      To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11,
      16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female
      Subjects Aged 9-45 Years.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Number of Subjects Reporting Solicited Adverse Events

Secondary Outcome

 Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58

Condition

Cervical Cancers

Intervention

9-valent HPV Recombinant Vaccine

Study Arms / Comparison Groups

 9-valent HPV Recombinant Vaccine

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

90

Start Date

October 10, 2018

Completion Date

January 10, 2020

Primary Completion Date

August 20, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy females between, and including, 9 and 45 years of age at the time of enrolment

          -  Be able to provide legal identification for the sake of recruitment

          -  Be able to understand and sign informed consent form prior to enrollment and for
             subjects aged 9-17 years, they and their legal guardian(s) are supposed to understand
             and sign informed consent form together

          -  Subjects who the investigator believes that they can and will comply with the protocol
             requirements

          -  Subject must be not pregnant at the enrollment and agree to use adequate contraceptive
             precautions within 7 months or don't have pregnancy plan

        Exclusion Criteria:

          -  Fever or axillary temperature> 37.0℃ before vaccination

          -  Previous vaccination against HPV

          -  Planned administration/administration of investigational or non-registered product
             (drug or vaccine) other than the study vaccine within 30 days preceding first dose of
             vaccine

          -  Planned to take part in other clinical research within 7 months after participating
             this study or have taken part in other clinical research within 3 months before
             participating this study

          -  Abnormal laboratory tests parameters(except the part the clinician diagnosed as non
             clinical significance)

          -  Administration of any whole blood, plasma or immunoglobulins products within 3 months
             preceding first vaccination

          -  Interval between administration of the study vaccination and any attenuated live
             vaccine less than 14 days, and other vaccines less than 10 days

          -  History of serious allergic disease requiring medical intervention (such as oral and
             throat swelling, difficulty breathing, hypotension or shock)

          -  History of to adverse event to vaccine, or allergic to some food or drug

          -  History of epilepsy, seizures or convulsions, or family history of mental illness

          -  Subjects are immunocompromised or have been diagnosed as suffering from congenital or
             acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus
             erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation
             (JRA), inflammatory bowel disease or other autoimmune diseases, administration of
             immunosuppressants with six months prior to the first vaccine dose.

          -  Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy

          -  Subject to severe hepatorenal disease, cardiovascular disease, hypertension, diabetes,
             malignant tumor, all kinds of infectious diseases and acute illness, or during chronic
             disease acute attack period

          -  Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency,
             coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder

          -  Breastfeeding, pregnancy (including pregnancy test positive), or planned to be
             pregnant within 7 months

          -  During acute disease (including infectious and non-infectious disease) and chronic
             diease period of onset

          -  Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that
             relevant to HPV infection in the past two years

          -  Planned to move out of local before the end of the study or leave the local for a long
             time during the study period

          -  Other unsuitable factors for the study judged by investigators
      

Gender

Female

Ages

9 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

China

Location Countries

China

NCT ID

NCT03676101

Organization ID

9-HPV-1001

Responsible Party

Sponsor

Study Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Collaborators

 Chongqing Bovax Biopharmaceutical Co., Ltd.

Study Sponsor

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Verification Date

January 2020