Clinical study of immunogenicity and safety of human papilloma virus vaccine (quadrivalent, produced by Biosun pharmed Co.) compared to Gardasil vaccine (quadrivalent, produced by Merck Co.) in healthy adults aged 15-35 years
- Conditions
- Cervical cancer.Malignant neoplasm of cervix uteri
- Registration Number
- IRCT20230508058114N1
- Lead Sponsor
- Biosun pharmed pharmaceutical company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 450
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Human papilloma virus type 16 antibody titer, GMT. Timepoint: Seven months after first injection. Method of measurement: ELISA method.;Human papilloma virus type 18 antibody titer, GMT. Timepoint: Seven months after first injection. Method of measurement: ELISA method.;Human papilloma virus type 6 antibody titer, GMT. Timepoint: Seven months after first injection. Method of measurement: ELISA method.;Human papilloma virus type 11 antibody titer, GMT. Timepoint: Seven months after first injection. Method of measurement: ELISA method.
- Secondary Outcome Measures
Name Time Method