A Blind, Randomized and Placebo-controlled Clinical Trial With Recombinant HumanPapillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Health Women-Phase I

Shanghai Zerun Biotechnology Co.,Ltd1 site in 1 country160 target enrollmentFebruary 2012

ConditionsHuman Papillomavirus

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Human Papillomavirus
Sponsor: Shanghai Zerun Biotechnology Co.,Ltd
Enrollment: 160
Locations: 1
Primary Endpoint: Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions.
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

December 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Shanghai Zerun Biotechnology Co.,Ltd

Responsible Party

Sponsor

Eligibility Criteria

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.