Evaluate the Safety of Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Healthy Females
NCT ID: NCT01548118
Last Updated: 2012-03-08
Study Results
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Basic Information
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UNKNOWN
PHASE1
160 participants
INTERVENTIONAL
2012-02-29
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Adult Group 1, HPV vaccine 0.5ml
20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines.
HPV 16/18 vaccine, 0,5ml
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Adult Group 1, Placebo 0.5ml
20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate.
Placebo control, 0.5ml
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Adult Group 2, HPV vaccine 1.0ml
20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines.
HPV 16/18 vaccine, 1.0ml
Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Adult Group 2, Placebo 1.0ml
20 women between 18-45 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate.
Placebo control, 1.0ml
Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Children Group 1, HPV vaccine 0.5ml
20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml experimental HPV vaccines.
HPV 16/18 vaccine, 0,5ml
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Children Group 1, Placebo 0.5ml
20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 0.5ml aluminum phosphate.
Placebo control, 0.5ml
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Children Group 2, HPV vaccine 1.0ml
20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml experimental HPV vaccines.
HPV 16/18 vaccine, 1.0ml
Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Children Group 2, Placebo 1.0ml
20 girls between 9-17 yeas of age, receiving 0,2,6 month-schedule of 1.0ml aluminum phosphate.
Placebo control, 1.0ml
Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Interventions
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HPV 16/18 vaccine, 0,5ml
Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Placebo control, 0.5ml
Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
HPV 16/18 vaccine, 1.0ml
Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Placebo control, 1.0ml
Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
Eligibility Criteria
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Inclusion Criteria
* 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 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
9 Years
45 Years
FEMALE
Yes
Sponsors
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Shanghai Zerun Biotechnology Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Yan-ping Li, MD
Role: PRINCIPAL_INVESTIGATOR
Guangxi Centers for Disease Control and Prevention
Locations
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GuangXi Center for Diseases Control and Prevention
Nanning, Guangxi, China
Countries
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Other Identifiers
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311-HPV-1001
Identifier Type: -
Identifier Source: org_study_id
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