Study for Safety , immunogenicity and efficacy of intramuscular administration of Haemophilus Influenzae type b conjugate vaccine manufactured by Masoondarou Co. (MAS-HibVAC®) in 50 children and compare with foreign sample

Masoondarou Co.0 个研究点目标入组 50 人开始时间: 待定最近更新: 2018年2月22日

适应症

试验速览

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•Inclusion Criteria :
•1-Male or females age 2-4 months.
•2- Generally in good Health .
•3- Written informed consent by the legal guardians.
•4- No Known immunological deficiency, including HIV infection .
•5- No known serious diseases, including diabetes , and epilepsy .
•6- No involvement in other drug or vaccine clinical trials during the study period .
•7- No current or foreseeable use of immunosupressors within 1 month prior to vaccination and during the period of study .
•8- No known allergy to biological products .
•9- No history of vaccination against Haemophilus Influenzae type b .
•10- No fever at the time of vaccination ( oral body temperature > 37.5 C ) .
•11- No known allergy to a vaccine component. Exclusion criteria :
•1- Need for use of special drugs ( immunosupressores ,…………) during of the trial .
•2- Withdrawal of consent by the legal guardians .
•3- Evidence of any unusual condition in volunteer on the basis of trial medical team idea ( serious diseases , surgery , …………) .
•4- Evidence of any serious diseases , including diabetes , and epilepsy .
•5- Abnormal results of hematology and biochemistry tests such as lococytopenia , lococytosis , thrombocytopenia , anemia , hypercalemia , hypocalemia , hypernatremia , hyponatremia ,…….

发起方

Masoondarou Co.