A Phase IV, Multicenter, Open label, Post marketing study to assess the immunogenicity and safety of DTPw-Hep B-Hib (PRP-T) vaccine (pentavac) (adsorbed) manufactured by Serum Institute of India ltd. in infants aged 2-7 months in Alborz Province, Iran

Biosun Farmed (Barkat Foundation)0 个研究点目标入组 691 人开始时间: 待定最近更新: 2018年2月22日

研究概览

暂无简介。

•Healthy infants of either sex aged 2 months at the time of first dose injection; Free of obvious health problems as established by medical history and clinical exam before entering into the study; Born after normal gestational age (36-42 weeks); Written, explained, and signed informed consent form of infant’s parents; Born to sero-negative HBsAg mothers (based on pregnancy documents or mother declaration); Born to sero-negative HIV mothers (based on pregnancy documents or mother declaration); The infant should be receive vaccination of 2/4/6 months at the same clinic and should be available after last vaccination up to two months
•Exclusion criteria: Use of any investigational drug or vaccine other than Pentavac during the study period or within 30 days prior the first vaccine dose; Administration of immunoglobulins or any other blood products since birth; Administration of a routine vaccine 30 days before or during the study period except BCG and OPV vaccine; History of significant and persistent hematologic, hepatic, renal, cardiac or respiratory disease; Evidence of any acute infection or fever; Axillary temperature = 38.5°C; History of neurological disorders or seizure; History of allergic disease or reactions which is possibly exacerbated by any component of vaccine; Confirmed immunosuppression including HIV infection; Any congenital or hereditary immunodeficiency; Simultaneous participation in any other clinical study

发起方

Biosun Farmed (Barkat Foundation)