Clinical trial of the immunogenicity and safety of Papilloguard 4 vaccine (quadrivalent manufactured by Nivad Pharmed Salamat company) compared to Gardasil vaccine (quadrivalent, reference product, Merck company) by comparing the ratio of GMT (Geometric Mean Titer) in healthy male and female volunteers 15 to 25 years: a phase 3 randomized, parallel, double-blind, noninferiority clinical trial

ivad Pharmed Salamat0 个研究点目标入组 670 人开始时间: 待定最近更新: 2024年5月27日

适应症

试验速览

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•Males and females 15 to 25 years old
•Eligible for general health (through clinical examinations and medical records)
•Signed the informed consent form (or guardian has signed the informed consent form)
•It is possible to accompany the visit programs and the study process within 7 months
•Not having fever (above 37.5°C) or acute infectious disease within 24 hours of participation
•If the female volunteer had sex within two weeks before entering the study, she must have used a suitable method of prevention (other than emergency pills)
•Women volunteer must not be pregnant and should agree to use effective preventive method through 7 months of the study
•Not having a plan to inject other vaccines in the study period (except Meningococcal, hepatitis B, influenza, diphtheria/tetanus vaccines, or injection of diphtheria/tetanus vaccine 8 days before participation with the prior consultation of PI).

•Received any prior doses of HPV vaccine
•A history of severe allergic reactions (swelling of the mouth and throat, dyspnea, hypotension, urticaria, shock) that require therapeutic interventions.
•History of alcohol or drug abuse (addiction) within 1 year before entering the study
•Subjects who are thrombocytopenic or suffering from any coagulation disorder that prohibits intramuscular injection.
•Breastfeeding women
•Subjects with immune-mediated disease include: splenectomy, subjects who have immune disorders (e.g. lupus, rheumatoid arthritis), currently taking immunosuppressant medication (including radiation therapy, anti-metabolites, taking systemic corticosteroids in the last three weeks more than 15 mg daily), people who are currently undergoing chemotherapy
•History of chronic diseases e.g. cancer, liver and kidney diseases, chronic lung disease, heart failure, thyroid disorders, neurologic disorders, diabetes, autoimmune disease
•Receiving immunoglobulins or blood products within 6 months before participation and not having a plan to receive through 7 months of the study.
•Any other condition outside of the above that, in the opinion of the researcher/doctor, makes the candidate unsuitable for participating in the clinical trial.
•Participation in other clinical trials

发起方

ivad Pharmed Salamat