Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 9-valent HPV Recombinant Vaccine
|
Biological: 9-valent HPV Recombinant Vaccine
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
|
| Placebo Comparator: Placebo
|
Biological: Placebo
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects Reporting Solicited Adverse Events [7 days after each vaccination]
- Number of Subjects Reporting Unsolicited Adverse Events [30 days after each vaccination]
- Number of Subjects Reporting Serious Adverse Events [30 days after third dose of vaccination]
Secondary Outcome Measures
- Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58 [30 days after third dose of vaccination]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy females between, and including, 9 and 45 years of age at the time of enrolment
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Be able to provide legal identification for the sake of recruitment
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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
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Subjects who the investigator believes that they can and will comply with the protocol requirements
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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:
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Fever or axillary temperature> 37.0℃ before vaccination
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Previous vaccination against HPV
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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
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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
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Abnormal laboratory tests parameters(except the part the clinician diagnosed as non clinical significance)
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Administration of any whole blood, plasma or immunoglobulins products within 3 months preceding first vaccination
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Interval between administration of the study vaccination and any attenuated live vaccine less than 14 days, and other vaccines less than 10 days
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History of serious allergic disease requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
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History of to adverse event to vaccine, or allergic to some food or drug
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History of epilepsy, seizures or convulsions, or family history of mental illness
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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.
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Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
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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
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Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
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Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months
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During acute disease (including infectious and non-infectious disease) and chronic diease period of onset
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Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years
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Planned to move out of local before the end of the study or leave the local for a long time during the study period
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Other unsuitable factors for the study judged by investigators
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejiang Provincial Center for Disease Control and Prevention | Hanzhou | China |
Sponsors and Collaborators
- Shanghai Bovax Biotechnology Co., Ltd.
- Chongqing Bovax Biopharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9-HPV-1001