Human Papillomavirus
Conditions
Keywords
Human papillomavirus, vaccine, cervical infection, cervical cancer
Brief summary
This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.
Interventions
BIOLOGICALHPV 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
BIOLOGICALPlacebo 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.
BIOLOGICALHPV 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
BIOLOGICALPlacebo 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.
Sponsors
Shanghai Zerun Biotechnology Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 45 Years
Healthy volunteers
Yes
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions. | 7 days after each vaccine dose |
| Occurrence, intensity and relationship to vaccination of any unsolicited symptom. | 30 days after finish vaccinations |
Secondary
| Measure | Time frame |
|---|---|
| Neutralizing antibody responses of HPV 16/18 after each vaccine dose. | 30 days after finish vaccinations |
Countries
China
Outcome results
None listed