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IRCT201008084536N1 IRCT 2012-03-05 Masoondarou Co. Study for effects of Haemophilus Influenzae type b conjugate vaccine in children 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 2012-04-20 anticipated 50 Complete https://irct.ir/trial/4842 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention. N/A Children Haemophilus Meningitis. Intervention 1: interment 2 Hib polysaccharide – tetanus toxoid conjugate vaccine manufactured by Novartis. Intervention 2: Interment 1 is Hib polysaccharide – tetanus toxoid conjugate vaccine manufactured by MASOONDAROU Co. (MAS-HibVAC®).
public Zolfagharian H
Simindasht Industrial City
Karaj Iran (Islamic Republic of) +98 26 1667 0350 zolfagharianh@yahoo.com Masoondarou Co. scientific Sanaie Anahita
Hore Square , Kamali Street
tehran Iran (Islamic Republic of) +98 21 5541 9007 anahita_sam@yahoo.com Shahid Beheshti University of Medical Science Iran (Islamic Republic of) 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 Ċ ) . 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 ,……. 1 year 1 year Both G00.0 Meningitis due to Haemophilus influenzae Prevention Prevention interment 2 Hib polysaccharide – tetanus toxoid conjugate vaccine manufactured by Novartis Interment 1 is Hib polysaccharide – tetanus toxoid conjugate vaccine manufactured by MASOONDAROU Co. (MAS-HibVAC®) Occurrence any local and systemic adverse effects. Timepoint: 8th, 16th and 20th weeks. Method of measurement: Paraclinical assesment, clinical examination and Diary card reports. Immunogenicity. Timepoint: At the Day 30 after the end of injection. Method of measurement: Elisa. Efficacy. Timepoint: At Day 30 after the end of injection. Method of measurement: Bactricidal effect of serum of volunteers. Effects of vaccines on the functions of blood system. Timepoint: Before vaccine administration and 30 days after end vaccine injection. Method of measurement: Paraclinical tests. Effects of vaccines on the functions of hepatic and renal system. Timepoint: Before vaccine administration and 30 days after end vaccine injection. Method of measurement: Paraclinical tests. Effects of vaccines on the functions of nervous system. Timepoint: All of study duration. Method of measurement: Clinical examination. Effects of vaccines on the functions of cardiac and respiratory systems . Timepoint: All of study duration. Method of measurement: Clinical examination. Masoondarou Co. Approved 2012-02-18 Research Deputy of Shahid Beheshti Medical Univercity Shahid Beheshti Medical Univercity, Shahid Chamran Exp. Way (Evin) . Tehran Iran (Islamic Republic of)