The annual incidence of bacterimia and meningitis caused by Haemophilus influenzae type b (Hib) among the children in the firs 5 years of life is in the range 0.02 – 0.5 % with mortality of 5 – 10 % . Hib polysaccharide conjugate vaccines showed to be a effective means of protecting against such infections .
The objective of the study is evaluate safety , immunogenicity and efficacy of intramuscular administration of Hib conjugate vaccine manufactured by Masoondarou Co. (MAS-HibVAC®) in 50 children and compare with foreign sample .
Trial design : The trial is a bridging study , Double-blind , multicentric Comparator-controlled , Randomized .
A -Trial Volunteers :
- Primary inclusion criteria to the trial : Male or females age 2-4 months , good Health , informed consent by the legal guardians , No Known immunological deficiency , No known serious diseases, No involvement in other drug or vaccine clinical trials , No known allergy to biological products .
- Primary Exclusion criteria to the trial : Need for use of special drugs during of the trial , Withdrawal of consent by the legal guardians , evidence of any unusual condition in volunteer , evidence of any serious diseases and abnormal results of paraclinical tests .
- Sample size : 50 volunteers will be enrolled in the study and each of the volunteers monitored for a maximum 6 months .
B- Interventions :
Interment 1 is Hib polysaccharide – tetanus toxoid conjugate vaccine manufactured by MASOONDAROU Co. (MAS-HibVAC®) and interment 2 Hib polysaccharide – tetanus toxoid conjugate vaccine manufactured by Sanofipasteur Co. (ActHib®) each with dose of 0.5 milliliter .
C- Intervention time :
Volunteers will be vaccinated by 2 dose of vaccines intramuscularly with 2 months interval .
D- Trial Endpoints :
Primary endpoints includes occurrence any local and systemic adverse effects , Hib anticapsular antibody titer in serum of children before and after vaccination , efficacy of vaccines and secondary endpoints effects of vaccines on the functions of blood , hepatic , renal , nervous , cardiac and respiratory systems .