Clinical study of immunogenicity and safety of human papilloma virus vaccine (quadrivalent, reference product, produced by Biosun pharmed Co.) compared to Gardasil vaccine (quadrivalent, produced by Merck Co.) in healthy adults aged 15-35 years: A phase 3, randomized, double-blinded, parallel, active-controlled, non-inferiority clinical trial

Biosun pharmed pharmaceutical company0 个研究点目标入组 450 人开始时间: 待定最近更新: 2023年5月29日

试验速览

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•Age 15-35 years, Both genders
•The volunteer and/or their guardian have the ability to understand the conduct process of the study and the willingness to attend visits, injections, and other processes in the protocol.
•The volunteer and/or their guardian have the ability to fully understand the contents of the informed consent form and sign it before entering the study.
•General health confirmed by medical history and physical examination by physician.
•Not having infection and inflammation in uterus or genital area based on physician examination.
•Not having fever (Temperature >37.5 C) or an acute infectious disease in the last 24 hours before injection
•Not having a plan to inject other vaccines in the study period (meningococcus, hepatitis B, Inactive influenza, Covid-19 and dT containing vaccines are allowed until 8 days before HPV vaccine)
•Not using vaginal products or having sexual intercourse 48 hours before each visit
•Using Contraception method (other than emergency pills) in case of sexual intercourse in two weeks before study entry
•Seronegative for Anti HPV 6,11,16,18
•Not being pregnant (Blood beta hCG) and agree to use contraception method for 7 months.

•History of abnormal pap smear or biopsy
•Having or the history of having genital wart
•History or active HPV infection
•Prior HPV vaccination
•History of any vaccine injection in the last 21 days before study entry
•History of severe allergic reactions to vaccine which needs treatment.
•History of hypersensitivity to vaccine ingredients
•Receiving immunoglobulins or blood products in the six months prior to study entry or having a plan to use them in the seven months following study entry.
•Chronic diseases such as liver, renal, uncontrolled hypertension, diabetes mellites type 1 or 2, gestational diabetes, chronic pulmonary diseases, heart failure, thyroid diseases, neurologic diseases and malignancies
•Immunodeficiency or immune related disorders
•Thrombocytopenia or any coagulation disorder with contraindication for IM injection
•History of drug or alcohol abuse in the 12 months prior to study entry.
•Severe psychiatric diseases affecting the study participatin
•Intention for pregnancy in the following 7 months
•Concurrent participation in other studies
•Any other conditions that make the volunteer unsuitable for the study (Investigator opinion)
•For second and third injection: Severe adverse events related to the previous injections

发起方

Biosun pharmed pharmaceutical company