Human Papillomavirus Clinical Trial
Official title:
Immunogenicity and Safety of Recombinant Human Papillomavirus Bivalent(Type 16 and 18) Vaccine (Yeast) in Healthy Females
Verified date | April 2023 |
Source | Shanghai Zerun Biotechnology Co.,Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26 years age group and 27-45 years age group in terms of immunogenicity.
Status | Completed |
Enrollment | 1200 |
Est. completion date | December 2017 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 9 Years to 45 Years |
Eligibility | Inclusion Criteria: - Healthy female between, and including, 9 and 45 years of age at the time of the first vaccination - Provide legal identification for for the sake of recruitment - Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition). - Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months. Exclusion Criteria: - History of cervical cancer - Previous administration of any HPV vaccine - History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock) - History of allergic to vaccine, or to any ingredient of vaccine. - 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. - History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant - Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy - Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder - Acute disease or chronic disease acute exacerbation 7 days prior to vaccination - Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days. - Fever or axillary temperature> 37.0 °C before vaccination - During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month - History of hypertension, physical examination systolic blood pressure> 150mmHg and/or diastolic blood pressure> 100mmHg - Abnormal laboratory tests parameters - Any clinical significant disease or findings during study screening that, in the opinion of the Investigator may interfere with the study |
Country | Name | City | State |
---|---|---|---|
China | GuangXi Center for Diseases Control and Prevention | Nanning | Guangxi |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zerun Biotechnology Co.,Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The neutralizing antibody responses of HPV 16/18 after vaccination by measuring Geometric Mean Titer (GMT). | 1 month after vaccination | ||
Secondary | Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions | 7 days after each vaccine dose | ||
Secondary | Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions | 6 months after finish vaccinations | ||
Secondary | The durability of neutralizing antibody responses of HPV 16/18 after vaccination. | 48 months after finish vaccinations |
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